MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*PPH PROCEDURE SET; STAPLE, IMPLANTABLE

Catalog Number PPH03

Device Problems Use of Device Problem (1670); Failure to Fire (2610)

Patient Problems Failure to Anastomose (1028); Fistula (1862); Pain (1994)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).Publication year of 2014.Batch # unk.This report is related to a journal article; therefore no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (pph03) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (pph03) used in this procedure? what is number of patients in longo anopexy group who had median pain of 3 and if this is related to the pph03 stapler? (b)(4).

Event Description

It was reported via literature entitled: a prospective and comparative study between stapled hemorrhoidopexy and hemorrhoidal artery ligation with mucopexy author(s): a.Béliard, f.Labbé, d.De faucal, j.-m.Fabreguette, p.Pouderoux, f.Borie citation: journal of visceral surgery (2014) 151, 257¿262; doi: http://dx.Doi.Org/10.1016/j.Jviscsurg.2014.03.009.The aim of this study was to show the effectiveness of transanal hemorrhoidal artery ligation under doppler control(thd) with mucopexy (m) for the treatment of grades ii and iii hemorrhoidal disease and to compare its results with the longo anopexy technique.From jun 2009 to jan 2011, 81 patients (n=36 female and n=45 male) with grades ii and iii hemorrhoidal disease underwent thdm (n=54; mean age of 51.2±12.6 years) and longo anopexy (n=27; mean age of 47.4±9.7 years).In thd group, dearterializations accomplished by suture ligation with interrupted vicryl2.0 stitches.In longo anopexy, a purse-string suture of 2¿0 prolene is placed circumferentially in the mucosa and sub-mucosa 2¿3 cm above the dentate line.A circular stapler designed for prolapsing hemorrhoids (pph 03, ethicon endo-surgerytm, ohio, usa) is introduced with the anvil above the purse-string suture, which is then tightened down around the central post of the stapler.The pph 03 stapler is then closed and fired resecting the tissue while placing a double circular row of staples.At discharge in longo anopexy group, median pain score of 3 was reported (n=?).Furthermore in the same group, complications included failure of intraoperative circular stapling (n=1) in which it failed to fire the staple line while dividing the mucosa and submucosa, requiring closure of the transection with hand-sewn suture line; and rectovaginal fistula 15 days after surgery in which patient underwent an attempted closure with biological glue at one month postop and mucoplasty closure with biological glue to close the fistula at two months.And finally at six months, she underwent successful second mucosal flap closure combined with diverting colostomy which was closed three months later.The effectiveness of these two techniques in treating prolapse and bleeding is due to the fact that both techniques treat the cause by controlling the blood flow in the hemorrhoidal tissue and mucosal prolapse by mucopexy or anopexy.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8704051
• MDR Text Key: 148270708
• Report Number: 3005075853-2019-19792
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036013006
• UDI-Public: 10705036013006
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PPH03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention