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

Catalog Number	STR5G
Health Effect - Clinical Codes	Incontinence (1928); Pain (1994); No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: unknown.Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure?.
Event or Problem Description
It was reported via journal article: title: pelvic floor function following ventral rectopexy versus starr in the treatment of obstructed defecation.Author/s: d.F.Altomare, a.Picciariello, r.Memeo, m.Fanelli, r.Digennaro, n.Chetta, m.De fazio.Citation: techniques in coloproctology (2018) 22: 289¿294; https://doi.Org/10.1007/s10151-018-1776-3; published online: 28 march 2018.This retrospective study aimed to compare the functional outcome of stapled transanal rectal resection (starr) and ventral rectopexy (vrp) in a series of ods patients, with regard not only to defecation but also to overall pelvic floor function.Between 2006 to 2016, forty-nine female patients who had surgery for ods were evaluated.Twenty-eight patients (median age 60, range 54-69 years) had vrp and 21 patients (median age 58 range 51-66 years) had starr.Ventral rectopexy (vrp) was performed by laparoscopy, using resorbable (biological) or unresorbable meshes.Stapled transanal rectal resection (starr) was done by resection of the rectocele and the rectal intussusception by two circular staplers (pph01 ethicon endosurgery) or a rechargeable curved linear stapler (contour transtar, ethicon endosurgery).Complications included urgent defecation (n=2), soiling (n=1), fecal incontinence (n=1), prolonged anal pain (n=1) and persisting obstructed defecation (n=8).In conclusion, vrp and starr can improve defecation in patients with ods with minimal complications, but the overall pelvic wellness evaluated by the tape score improves significantly only after vrp, suggesting a better performance of vrp than starr when overall pelvic floor function is concerned.
Additional Manufacturer Narrative
Product complaint (b)(4).Corrected data: adverse event or product problem: update section to uncheck outcomes attributed to adverse event: update section to uncheck type of reportable event: not reportable.Patient codes.Additional information was requested and the following was obtained: does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? response: the postoperative complications described are related to the type of surgery, not to the performance of the ethicon product upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• 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: 8799239
• Report Number: 3005075853-2019-20458
• Device Sequence Number: 19542822
• Product Code: GDW
• UDI-Device Identifier: 10705036002871
• UDI-Public: 10705036002871
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: STR5G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/18/2019
• Patient Sequence Number: 1