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

Catalog Number	STR5G
Health Effect - Clinical Codes	Incontinence (1928); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Only publication year (2014) is known.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported via literature entitled: long-term results following transanal rectal resection in patients with obstructed defecation syndrome author: r.Prosst.Citation: coloproctology 2014 36:54¿55, doi 10.1007/s00053-013-0428-3; published online: 15/01/2014.The goal of this retrospective study was to investigate the functional long-term results and quality of life following transtar procedure surgery.The 77 consecutive patients (68 female) with obstructed defecation syndrome averaged 65 years of age (20-90 yrs.) were included in the study.The transtar operations occurred between january 2007 and march 2010.Contour transtar procedure allows achievement of a significantly larger resection than the starr procedure, due to better intra-operative view and monitoring.However, this did not result in any verifiable clinically functional improvement, at least within a brief follow-up observation period.Nine patients reported newly occurring post-operative incontinence for which additional treatment was required.This verifies that the incontinence frequently associated with a rectal prolapse should not be viewed as a surgical contraindication but continent patients should be notified of the possibility of incontinence following the transtar procedure.In conclusion, the transtar procedure was employed successfully for long-term treatment of obstructed defecation syndrome.Defecation urge and incontinence were observed, however, this usually improved within months.Therefore, the transtar procedure appears to be a sensible approach to the treatment of obstructed defecation syndrome.

• 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: 7742621
• Report Number: 3005075853-2018-11808
• Device Sequence Number: 1588220
• Product Code: GDW
• UDI-Device Identifier: 20705036002878
• UDI-Public: 20705036002878
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: 07/09/2018
• Initial Report FDA Received Date: 08/02/2018
• 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