MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR TRANSTAR STAPLER SET; STAPLE, IMPLANTABLE

Catalog Number	STR5G
Health Effect - Clinical Codes	Incontinence (1928); Pain (1994); Obstruction/Occlusion (2422); Blood Loss (2597)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2018.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.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.(b)(4).
Event or Problem Description
It was reported via literature entitled: laparoscopic ventral rectopexy versus stapled transanal rectal resection for treatment of obstructed defecation in the elderly: long-term results of a prospective randomized study.Authors: khaled m.Madbouly, m.D., ph.D., f.R.C.S.(glasg.), ahmed d.Mohii, m.D.Citation: disease of the colon and rectum (2019); 62(1):47-55.Doi: 10.1097/dcr.0000000000001256.The purpose of this study was to compare long-term functional outcome, recurrence rate, and quality of life between laparoscopic ventral rectopexy and stapled transanal rectal resection in the treatment of obstructed defecation.This prospective randomized study included 112 patients with obstructed defecation syndrome (ods) attributed to rectocele or internal rectal intussusception from may 2013 to april 2016.Patients were randomly allocated to group 1, 56 patients (11 male and 45 female; age range: 70-85 years; bmi: 28.3 ± 3.4) underwent laparoscopic ventral rectopexy (lvr), or group 2, 56 patients (18 male and 38 female; age range: 70-85 years; bmi: 29.1 ± 4.5) underwent stapled transanal rectal resection (starr).In group 2, patients had modified perineal stapled rectal resection with contour transtar (ethicon) for full-thickness rectal resection.Reported complications in group 2 included: bleeding (n-2), persistent obstructed defecation (od) complaints (n-6), prolonged anal pain (n-3) which only improved within 4 to 6 months, anal/fecal incontinence (n-3), soiling (n-1), fecal urgency (n-8), de novo anorectal and pelvic pain (n-3), and recurrence (n-11) in which the patients received biofeedback training, with minimal improvement regardless of the original procedure.In conclusion, laparoscopic ventral rectopexy has better long-term functional outcome, less complications, and less recurrences compared with stapled transanal rectal resection.

• Brand Name: CONTOUR TRANSTAR STAPLER SET
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8809905
• Report Number: 3005075853-2019-20556
• Device Sequence Number: 16829852
• Product Code: GDW
• UDI-Device Identifier: 10705036002871
• UDI-Public: 10705036002871
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: STR5G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention