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

Catalog Number	STR5G
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994); Thrombosis (2100); Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Only publication year (2010) 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: functional outcome and quality of life after stapled transanal rectal resection for obstructed defecation syndrome.Author : katja wolff, m.D.¿ lukas marti, m.D.¿ ulrich beutner, ph.D.Thomas steffen, m.D.¿ jochen lange, m.D.¿ franc h.Hetzer, m.D.Citation: dis colon rectum 2010; 53: 881¿888; doi: 10.1007/dcr.0b013e3181cdb445.The study aimed to determine functional outcome and quality of life after stapled transanal rectal resection (starr) for obstructed defecation syndrome (ods).Between jan2007 and nov2008, 52 female patients (median age of 64 years [20-87 years]) with ods underwent transtar procedure.Contour transtar-str5g stapler was used to complete the transtar procedure.Intraoperative complications included one patient who had staple line dehiscence fixed with additional sutures and recovered without any sequalae.At postoperative 5 weeks, one patient developed perianal venous thrombosis which required incision under local anesthesia.At 6-week follow-up, 2 patients had self-limiting rectal bleeding for which one patient persisted until the 3 month follow-up.Additionally, 2 patients had persisting pain caused by 2 residual staples treated by removal of staples without the need of anesthesia and patients recovered completely.Fecal urgency is a common postoperative finding of the procedure which occurred after low anterior resection for rectal cancer and in most cases lasted for approximately 6 to 12 months; reduction in rectal volume and different sensibility are one explanation.Fecal incontinence can be a typical symptom of ods.In cases where patients became incontinent after the transtar procedure, the author assume a pre-existing asymptomatic incontinence that appeared after anatomic restoration.The transtar procedure is an effective and safe procedure for a select group of patients with severe ods.

• 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: 7748033
• Report Number: 3005075853-2018-11851
• Device Sequence Number: 13892636
• 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): 07/10/2018

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: 07/10/2018
• Initial Report FDA Received Date: 08/03/2018
• 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