According to the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) stastical database, this device has had no less than 375 adverse events related to it since 1/1/2010. According to the site there have been 2 deaths and hundreds of injuries and malfunctions. Unfortunately the FDA has severely lapsed in its responsibility to provide a database that is stable. MAUDE was a congressionally driven requirements and it's not living up to the intent in its creation. The site itself will return different results even when the same variables are inputted. But according to the site this device, commonly known as PPH01, PPH02 and PPH03 (different production versions, PPH01 being the oldest) is malfunctioning, injuring and killing at what we see as alarming rates. Here is the text from the two cases of death (according to MAUDE):
DEATH 1
Catalog Number PPH03Event Date 01/26/2010
Event Type Death Patient Outcome Death Manufacturer Narrative (b) (4): info anticipated, but unavailable at this time. Event Description It was initially reported that during a rectal mucosal prolapse procedure, the firing handle could not be grasped completely and the device could not be fired. The doctor commented that he had used the device as usual and felt no difficulties at the firing. Another device was used to complete the procedure. There were no adverse consequences for the pt. Add'l info received on 2/3/2010. On (b) (6) 2010 (operation date): the doctor could not cut the washer completely and he felt difficulties at the firing. After the firing, he noticed that the tissue (12 to 3 o'clock) was not cut. Add'l suture was performed by hand and complete the case. The pt left the hospital. On (b) (6 )2010: the pt visited the hospital for pain in the groin. The doctor doubted the anesthesia. On (b) (6) 2010: the pt was transported by ambulance to the hospital. On (b) (6) 2010: ct scan was performed and the doctor confirmed that the anastomosis site was lacerated. As the pt was low pressure at the time, the doctor could not perform the reoperation. On (b) (6) 2010: the pt was death.
DEATH 2
Catalog Number PPH03
Event Type Death Patient Outcome Death Event Description: It was reported that there was very limited information, only that there has been an adverse incident involving a pph product. So far, it is unknown when this occurred or how. No device will be returning. Additional information has been requested. Manufacturer Narrative (b)(4) = colostomy). (b)(6) lady was admitted to (b)(6) hospital, treatment centre on (b)(6) 2010 for an elective procedure due to prolapsed haemorrhoids. The procedure went without apparent complication. Post operatively, she developed bleeding from rectum but the bleeding stopped spontaneously. Patient bled again on (b)(6) 2010, but this stopped spontaneously. On (b)(6) 2010, she suffered pain in her lower abdomen, a ct scan revealed air in the retroperitoneal space and query sepsis. She was on antibiotics. On (b)(6) 2010, a surgeon performed an emergency laparotomy. During the procedure, he noted disruption of the staple line. He proceeded to a sigmoid loop colostomy and washed out the retro peritoneal space. Patient was transferred post operatively to intensive care but condition deteriorated. Death confirmed at 1345hrs on (b)(6) 2010. A post mortem was completed and a cause of death was given as : multi organ failure; rectal perforation (operated on); haemorrhoids (operated on).
WE ARE VERY CONCERNED WITH THIS DEVICE AND THE FDA APPEARS TO BE POWERLESS IN ITS ABILITY TO RECALL THESE DEVICES. ALL RECALLS ARE BY THE MANUFACTURER ONLY---I.E. THE MANUFACTURER IS SELF REGULATING.
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ETHICON ENDO-SURGERY, LLC PROXIMATE PPH PROCEDURE SET
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