MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*HCS HEMORR CIR STAPL; STAPLE, IMPLANTABLE

Catalog Number	PPH01
Health Effect - Clinical Codes	Pain (1994); Blood Loss (2597); Not Applicable (3189); No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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: clinical outcomes of stapled transanal rectal resection for obstructed defaecation syndrome at 10-year follow-up authors: m.Schiano di visconte, f.Nicoli, a.Pasquali and g.Bellio citation: colorectal disease (2018); 2:614¿622.Doi:10.1111/codi.14028.The primary aim of this study was to evaluate the clinical outcomes and patients¿ satisfaction after stapled transanal rectal resection (starr) for obstructed defaecation syndrome (ods) at 10-year follow-up.The secondary aim was to define factors that predict the recurrence of ods after starr.This study was a retrospective cohort analysis conducted on prospectively collected data.Seventy-four consecutive patients (8 male and 66 female; mean age: 60.0 ±10.2; age range: 29-77 years) who underwent starr for ods between january 2005 and december 2006 in two italian hospitals were included.Three semi-circumferential purse-string sutures were placed in the anterior rectal wall and a 33-mm circular stapler (pph-01; ethicon) was inserted, closed and fired.Two semi-circumferential purse string sutures were positioned in the posterior rectal wall and a second pph-01 (ethicon) stapler was used.Reported complications included rectal bleeding (n-14) in which 7 patients were successfully managed conservatively and granulomatous foreign body reaction at the staple line (n-7) which required removal at the outpatient clinic.Reported complications during 3- month follow up included perineal pain (n-25) which were treated initially with painkillers (paracetamol or ketoprofen), 4 patients required staple line removal and mucosal layer reconstruction with resorbable suture, 4 patients were treated with nifedipine and 2 patients required chronic oral analgesics, urge to defecate (n-21) in which 13 patients were treated with biofeedback, oral gabapentin and beclomethasone suppositories without a significant improvement in symptoms and 3 patients were treated with sacral neuromodulation after conservative treatment failure with poor results, soiling (n-7), gas leakage (n-4), liquid leakage (n-1).At 12-month follow up, reported complications included perineal pain (n-21) which were treated initially with painkillers (paracetamol or ketoprofen), 4 patients required staple line removal and mucosal layer reconstruction with resorbable suture, 4 patients were treated with nifedipine and 2 patients required chronic oral analgesics, urge to defecate (n-14) in which 13 patients were treated with biofeedback, oral gabapentin and beclomethasone suppositories without a significant improvement in symptoms and 3 patients were treated with sacral neuromodulation after conservative treatment failure with poor results, soiling (n-5), gas leakage (n-3).At 3 ¿ year follow up, reported complications included perineal pain (n-14), urge to defecate (n-14), soiling (n-3), gas leakage (n-3), liquid leakage (n-3), ods recurrence (n-6), at 5 ¿ year follow up, reported complications included perineal pain (n-11), urge to defecate (n-13), soiling (n-3), gas leakage (n-3), solid leakage (n-1), ods recurrence (n-18).At 10-year follow up, reported complications included perineal pain (n-23), urge to defecate (n-13), soiling (n-4), gas leakage (n-4), liquid leakage (n-1), solid leakge (n-1), recurrence (n-24) in which 6 patients required laparoscopic ventral mesh rectopexy, 2 patients required transabdominal repair with rectal fixation, 2 patients required transvaginal posterior colpoperineorrhaphy and 1 patient required laparoscopic ventral mesh rectopexy along with starr.In conclusion, stapled transanal rectal resection significantly improves the symptoms of ods in the short term.In the long term starr is less effective, however.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8862219
• Report Number: 3005075853-2019-20932
• Device Sequence Number: 2390507
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K030925
• 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): 07/15/2019

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: PPH01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/05/2019
• 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: Hospitalization; Required Intervention