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

Catalog Number	STR5G
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119); No Consequences Or Impact To Patient (2199); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2014.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.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 author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.(b)(4).
Event or Problem Description
It was reported via literature entitled: starr with contour® transtar¿ device for obstructed defecation syndrome: one-year real-world outcomes of the european transtar registry.Authors: g.Ribaric, a.D¿hoore, g.Schiffhorst and e.Hempel.Citation: int j colorectal dis (2014) 29:611¿622; doi 10.1007/s00384-014-1836-8; published online: 21 february 2014.This prospective cohort study aimed to assess the short-term safety and effectiveness of transtar in the real-world clinical environment where the variation phenomenon exists.Between january 2009 to january 2011, 100 patients (mean age 60 years, range 27-82, female n=98, male n=2) with ods underwent transtar.The contour transtar stapling kit (ethicon endo-surgery inc., cincinnati, oh, usa) was opened and the circular anal dilator (cad) was gently introduced and fixed to the perianal skin with four cardinal sutures.A swab was inserted and gently pulled outward to visualize the apex of the intussusception.Finally, the transtar technique was performed in three steps: step 1: parachute suture placement, step 2: opening of the prolapse, and step 3: circumferential resection.Intraoperative complications included partial dehiscence of staple line (n=1) and spiraling of staple line (n=2).The partial dehiscence of the staple line in one patient required immediate additional suturing with no further surgical re-intervention.The spiraling of the staple line in two patients required conservative treatment by observation and oral antibiotic medication with no further surgical treatment.Postoperative complications included bleeding (n=5), urinary retention (n=2), and persistent pain (n=1).Prolonged persistent pain in one patient required removal of retained staples (agraphectomy).One patient with postoperative bleeding received conservative treatment, and in one patient the observed perirectal hematoma required surgical re-intervention.In three patients, self-limiting rectal bleeding was notified.Acute urinary retention occurred in two patients requiring interventions without anesthesia.In conclusion, transtar facilitated a tailored, real circumferential full-thickness rectal resection, leading to improved patient functional and quality of life outcomes at 12 months postoperatively.It represents a safe and effective treatment for ods in local clinical practice, although the sustainability of real-world results needs to be proven in the long-term follow-up.
Additional Manufacturer Narrative
Product complaint (b)(4).Additional information was requested and the following was obtained: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? answer: ethicon device functioned well and did not contribute to the complications mentioned in the article.Upon review of the information provided that the "ethicon device functioned well and did not contribute to the complications mentioned in the article", 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: 8808543
• Report Number: 3005075853-2019-20511
• Device Sequence Number: 16225071
• 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,Followup
• Report Date (Section B): 06/24/2019

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
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/02/2019
• 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