MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*MULTIFEED STAPLER; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number EMS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: 2007.Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported via journal article: title: discomfort five years after laparoscopic and shouldice inguinal hernia repair: a randomized trial with 867 patients.A report from the smil study group.Authors: fritz h.Berndsen, u.Petersson, d.Arvidsson, c.-e.Leijonmarck, c.Rudberg, s.Smedberg and a.Montgomery.Citation: hernia (2007) 11:307-313: doi 10.1007/s10029-007-0214-7.This randomized multicenter trial aimed to compare five-year results regarding discomfort after tapp and shoudice repair and correlate early postoperative events with persisting discomforts.Between february 1993 to march 1996, 1068 male patients between 30 and 70 years with unilateral primary inguinal hernia were operated with tapp (n=538) and shouldice (n=530).In the tapp procedure, a 7cm x 12cm polypropylene mesh (prolene; ethicon, somerville, nj, usa) was inserted and fixed by use of an endoscopic stapler (ems multifeed staplegun; ethicon).Complications included hematoma (n=49); mild discomfort (n=48), moderate discomfort (n=16) and severe discomfort (n=1) at 1 year follow up; mild discomfort (n=44), and moderate discomfort (n=11) at 2 years follow up; mild discomfort (n=44), and moderate discomfort (n=11) at 3 years follow up and mild discomfort (n=24), moderate discomfort (n=12) and severe discomfort (n=1) at 5 years follow up.In conclusion, there was no difference between late discomfort at five-year follow up after laparoscopic tapp and shouldice repair.Discomfort was mostly mild and pain during the first postoperative week was a prognostic variable for late discomfort in shouldice patients.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 8807572
• MDR Text Key: 151601538
• Report Number: 3005075853-2019-20526
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K913469
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EMS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1