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

Catalog Number	STR5G
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date of event: publication year of 2008.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.(b)(4).
Event or Problem Description
It was reported via literature entitled: the laparoscopic-assisted transanal resection of the external primary and recurrent rectum prolapse using the stapler system.Author : tom g.Kirchner, omid abri.Citation: coloproctology 2008;30:11¿5; doi 10.1007/s00053-008-8002-5.This study aimed to present the newly developed contour transtar system for s.T.A.R.R.For its highest possible safety to patient and to rule out any possible enterocele or adhesions in the lesser pelvis or to release the same.A total of 8 patients (average age of 76 years) with an external primary and recurrent rectum prolapse underwent a laparoscopic-assisted with contour transtar system for s.T.A.R.R.In the procedure, after placing all radial (total of six) seams with vicryl® 2 × 0 and after placing the so-called loop seam with prolene® 2 × 0, the prolapse was opened with a conventional linear cutter at 03:00 lithotomy position and opened additionally with a blue 60 clip and 30 clip up to its base.The entire prolapse was then resection in a typical fashion with the supplied transtar¿-set and four to six clips on an average.Complications included arterial bleeding in the bracket seam area (n=1) requiring revision, imperative stool urgency (n=6) which was fixed under fibre-rich diet and after starting biofeedback therapy and initial high defecation frequencies of up to 10 times a day (n=?) which was controlled to a normal level of 3 defecations a day after 14 days under corresponding toilet conditioning (fibre diet, biofeedback, lopedium as needed, fixed timing and clarification).The laparoscopic-assisted transanal resection of the external primary and recurrent rectum prolapse using the contour® transtar¿ system for s.T.A.R.R.Of ethicon endo surgery represents an alternative to established procedures.

• 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: 8703966
• Report Number: 3005075853-2019-19790
• Device Sequence Number: 11285548
• Product Code: GDW
• UDI-Device Identifier: 10705036002871
• UDI-Public: 10705036002871
• 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: 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