MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.PROXIMATE PPH PROCEDURE SETSTAPLE, IMPLANTABLE

Catalog Number PPH03

Event Date 05/21/2012

Event Type  Injury   Patient Outcome  Other

Manufacturer Narrative

(b)(4). The analysis results found that the pph03 device arrived in good visual condition. The breakaway washer was present and cut and there were no staples present, indicating that the device achieved a full firing stroke. The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality. It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident. The staple line was complete and the staples were noted to have the proper b-formed shape. It should be noted that all devices are inspected 100% for staple presence by an automated vision system, and are visually inspected 100% as a final check. In addition, at finished goods the devices are visually inspected based on a sample. A batch record review was performed and no anomalies were found during the manufacturing process.

Manufacturer Narrative

(b)(4). Information anticipated, but unavailable at this time. Additional information provided: what does it mean the purse string was not cut? na. Are you referring the tags of the purse string? na. Was there any difficulty removing the device from the tissue? he opened the device with 1 counter-clockwise revolution. When the surgeon tried to remove the device, he couldn't remove it because the suture's still attached. Both side of the suture were still attached. He had to cut the suture in order to remove the device. Did change in technique impact patient post op care? he had to perform hemorrhoidectomy manual. The patient was discharged from hospital after 3 days. *the patient also had hernia surgery at the same time that day (hernia first then pph). When the device was fired, what was the location of the indicator within the gap setting scale? it was within the green range. Were any unexpected noises heard? no just the crack of the washer. Were any of the forces higher or lower than expected (closing, firing, or opening)? yes, it was very hard to fire. No problem when closing and opening regarding with forces of fire. Did a hcp other than the primary surgeon fire the instrument? if so, whom? no, the primary surgeon did the firing. What was the experience of the surgeon? this was his second case using pph03.

Event Description

It was reported that during a procedure for prolapse and hemorrhoids device was very hard to fire. The tissue doughnut was not complete, even the purse string was not cut. Internal hemorrhoids between 3 and 5 o'clock were not fixed, the doctor had to perform hemorrhoidectomy to this section -misaligned cutting formation.

• Brand Name: PROXIMATE PPH PROCEDURE SET
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section F): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR
• Manufacturer Contact: kathy rice ; 4545 creek rd; cincinnati , OH 45242-2803; (513) 337 -3299
• Device Event Key: 2647006
• MDR Report Key: 2616896
• Event Key: 2513592
• Report Number: 3005075853-2012-02827
• Device Sequence Number: 1
• Product Code: GDW
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Followup,Initial
• Report Date: 05/22/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/14/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device EXPIRATION Date: 08/28/2016
• Device Catalogue Number: PPH03
• Device LOT Number: H44T3C
• OTHER Device ID Number: BATCH #: H53284
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 06/18/2012
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 06/18/2012
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 09/28/2011
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Initial