MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN PREMIUM POLYSORB; STAPLE, IMPLANTABLE

Model Number	013501L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Post Operative Wound Infection (2446)
Date of Event	06/21/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: polysorbr(an absorbable lactomer) staples, a safe closure technique for distal pancreatic resection source: world j gastroenterol 2014 december 7; 20(45): 17185-17189 published online: december 7, 2014.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature, a study prospectively analyzed 150 patients who underwent distal pancreatectomy in the last 20 years.An auto suture stapler was used to ligate the splenic artery and vein in patients who underwent splenectomy.The device was used to amputate the pancreas and two staples were left in the proximal pancreatic stump.The average duration of the operation was 150 min (range: 90-210 min) and no transfusion was indicated during the operation.If bleeding was observed, another manufacture¿s suture was used to oversew the area of bleeding.Noted morbidity on 5 patients, but no mortality occurred in the postoperative period.Overall, the postoperative period was uneventful without any complications (pancreatic fistula, abscess, bleeding or wound infection) in 145 patients.It was stated that one post-operative pancreatic fistula which was treated with medication and jejunal feeding.Two patients suffered pancreatitis and reoperation due to bleeding.Reoperations were performed on two patients on the first or second postoperative day, necessitated by bleeding from the retroperitoneal region.Hospitalization was extended for patients with post-operative complications for 8 to 16 days.

• Brand Name: PREMIUM POLYSORB
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 11769832
• Report Number: 1219930-2021-01762
• Device Sequence Number: 4138866
• Product Code: GDW
• UDI-Device Identifier: 10884521047570
• UDI-Public: 10884521047570
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K830199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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 Model Number: 013501L
• Device Catalogue Number: 013501L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/04/2021
• 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: Hospitalization; Required Intervention