MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR TRANSTAR STAPLER SET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	STR5G
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.Date of event is unknown.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during review of journal article: title : combined transanal and laparoscopic approach for the treatment of deep endometriosis infiltrating the rectum author: vale´ rie bridoux, horace roman2,,*, babak kianifard1, maud vassilieff2, loi¨c marpeau2, francis michot1,, and jean-jacques tuech citation: human reproduction, vol.27, no.2 pp.418¿426, 2012; doi:10.1093/humrep/der422.This retrospective study aimed to describe a new technique for transanal full thickness disc excision of endometriotic nodules infiltrating the low and middle rectum, using the contour transtar stapler and to present data on the feasibility of this technique as an effective tool in the surgical management of dier.From april 2009 to october 2010, six nulliparous women (aged from 25 to 31 years old) were surgically managed for symptomatic dier.The first step is performed laparoscopically.Both pararectal spaces are opened below the lateral limits of the rectal nodule, the rectovaginal space is reached below the inferior limit of the nodule and the nodule is dissected away from the rectal wall, using the ultracision harmonic scalpel (ethicon endo-surgery inc., cincinnati, oh, usa).A transanal examination is undertaken to identify the height of rectal involvement from the anal margin.The circular anal dilator of the contour transtartm-str5g (ethicon endo-surgery inc.) stapling kit is then gently introduced into the anus and fixed to the perianal skin with four cardinal sutures.Using both transanal and laparoscopic views, an initial 2/0 prolene traction suture is placed in the centre of the nodule, along with two or three supporting sutures in order to completely enclose the nodule within the sutures.Two similar sutures are placed to the left and right side of the nodule and tied loosely to gain good traction on the captured tissue.The lubricated head of the contour transtar with opening jaws in the 3 o¿clock position, is introduced into the rectum.The instrument is then rotated counterclockwise and the nodule gently pulled inside the jaws until normal tissue can be seen seated within the proximal jaw of the device.The parachute sutures are pulled downward in the direction of the shaft of the contour stapler, thereby drawing the nodule along with a margin of normal tissue into the jaws of the stapler, the stapler retaining pin is applied and the stapler closed around the tissue.This closure is maintained for a period of 15 seconds in order to maximize tissue compression and subsequent haemostasis.The stapler is subsequently engaged and then removed.The final staple line is inspected for bleeding and secured with interrupted 3/0 vicryl as required.Complications included postoperative dysuria at 3 weeks on a (b)(6) year-old patient, postoperative dysuria at 6 days on a (b)(6) year-old patient and a slight defecation pain on (b)(6) year-old patient.In conclusion, despite the small numbers in this series, our data suggest that the new technique of transanal rectal disc excision using the contour stapler may be applied in patients with infiltrating endometrial nodules of the rectum up to 10 cm from the anal margin and up to 5 cm in diameter.This new procedure promises to be a useful addition to the surgeon¿s armamentarium in a multidisciplinary approach to deep pelvic endometriosis.

• Brand Name: CONTOUR TRANSTAR STAPLER SET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8799764
• Report Number: 3005075853-2019-20461
• Device Sequence Number: 327209
• Product Code: GDW
• UDI-Device Identifier: 10705036002871
• UDI-Public: 10705036002871
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: 06/20/2019
• Initial Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other