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

Catalog Number	STR5G
Health Effect - Clinical Codes	Fistula (1862); Incontinence (1928); Pain (1994); Sepsis (2067); Obstruction/Occlusion (2422); Blood Loss (2597)
Date of Event	01/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Date of event: publication year of 2013.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.The single complaint was reported with multiple events through a journal article.No specific patient information regarding events has been provided and it is unknown if the events have been previously reported.Attempts are being made to obtain the following information.If further details are received at the 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.What are the specific "others" adverse event noted in tables 2 and 3, and if the ethicon device caused/contributed to the reported events in the article? does the surgeon believe that ethicon products 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 used in this procedure? (b)(4).
Event or Problem Description
It was reported via literature entitled: emerging technologies in coloproctology: results of the italian society of colorectal surgery logbook of adverse events.Author : l.Basso, m.Pescatori, f.La torre, i.Destefano, a.Pulvirenti d¿urso, a.Infantino, a.Amato, aeco group.Citation: tech coloproctol (2013); 17:207¿211.Doi: 10.1007/s10151-012-0906-6.The aim of this study is to present the results of the italian society of colorectal surgery [or societa` italiana di chirurgia colorettale (siccr)] logbook of adverse event (ae) occurring in relation to emerging technologies in coloproctology (etcs), over a 3-year period.A total of 245 patients (155 male and 90 female; age range: 20-75 years) with ae were reported.The ¿¿observations¿¿ originated from the same institution of the aes in 44 cases, while 201 patients had been operated on somewhere else.The three most reported emerging technologies in coloproctology (etc) accounted for 227 observations: procedure for prolapsed haemorrhoids (pph [ethicon]; n = 120; 61 male and 59 female), stapled transanal rectal resection (starr) & starr with contour transtar (ethicon; n = 96; 12 male and 84 female), and transanal haemorrhoidal dearterialization (thd; n = 11; 10 male and 1 female).Reported complications in the pph group included chronic pain (n-46), obstruction (n-27), bleeding (n-19) which required surgical haemostasis, stenosis (n-19), prolapse (n-16), sepsis (n-14), frequency, incontinence, fractioned evacuation (n-14), fissure (n-10), fistula (n-6), perforation (n-6), urgency (n-3), tenesmus (n-3), and others (n-27).In starr group, reported complications included frequency, incontinence, fractioned evacuation (n-33), obstruction (n-26), chronic pain (n-21), bleeding requiring surgical haemostasis (n-18), prolapse (n-18), urgency (n-13), stenosis (n-10), tenesmus (n-4), sepsis (n-3), fistula (n-3), fissure (n-2), and others (n-11).In conclusion, etcs are important, yet they are not without major risks.Manufacturers should help colorectal surgeons to convey the right message to patients.

• 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: 8704169
• Report Number: 3005075853-2019-19799
• Device Sequence Number: 14020320
• Product Code: GDW
• UDI-Device Identifier: 10705036002871
• UDI-Public: 10705036002871
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/27/2019

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: 05/27/2019
• Initial Report FDA Received Date: 06/17/2019
• 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