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

Catalog Number	STR5G
Health Effect - Clinical Codes	Abdominal Pain (1685); Hematoma (1884); Pain (1994); No Code Available (3191)
Date of Event	01/01/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2010.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: severe mesorectal bleeding after stapled transanal rectal resection (starr-operation) using the contour transtar curved cutter stapler.Author: m.Gelos, k.Frommhold and b.Mann.Citation: the authors.Journal compilation 2010 the association of coloproctology of great britain and ireland.Colorectal disease, 12, 261¿266; doi:10.1111/j.1463-1318.2009.01965.X.This case report describes a (b)(6)-year-old female patient presented with a 10-year history of worsening outlet obstruction.She complained of incomplete evacuation, had used perineal support and inserted fingers into the vagina for evacuation.Proctoscopic examination revealed a large rectocele and a good sphincter pressure.Defecography showed a type i rectocele with a size more than 4 cm.Stapled transanal rectal resection by means of the contour transtar was performed.Forty-seven grams of rectal tissue was removed using six reloaded stapler cartridges.Digital examination revealed that the rectocele was completely removed.On the first postoperative day, the patient complained of acute pelvic and abdominal pain.Clinically, peritonism of the lower abdomen was found.Computed tomography was performed, which showed a large, circular haematoma within the mesorectum extending towards both kidneys.The haemoglobin value dropped from 12.2 g / dl (preoperative value) to 7.1 g / dl (12¿16 g / dl).The patient underwent laparotomy.Intraoperatively, a diffuse circular bleed within the mesorectum was found and was drained.The further postoperative course was uneventful.The s.T.A.R.R.Operation using the contour transtar curved cutter stapler is a new surgical technique in the treatment of ods, which seems to be safe and efficient in terms of amount of resected tissue.The presented complication has to be taken into consideration when using this new stapler device in the treatment of 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: 8806817
• Report Number: 3005075853-2019-20477
• Device Sequence Number: 14126671
• 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): 06/21/2019

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: 06/21/2019
• Initial Report FDA Received Date: 07/19/2019
• 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