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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE   Back to Search Results
Catalog Number PPH03
Event Date 05/21/2012
Event Type  Injury   Patient Outcome  Other
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.

 
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.

 
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.

 
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Brand NamePROXIMATE PPH PROCEDURE SET
Type of DeviceSTAPLE, 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 Key2647006
MDR Report Key2616896
Event Key2513592
Report Number3005075853-2012-02827
Device Sequence Number1
Product CodeGDW
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 Received06/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date08/28/2016
Device Catalogue NumberPPH03
Device LOT NumberH44T3C
OTHER Device ID NumberBATCH #: H53284
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/18/2012
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/18/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/28/2011
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

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