MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PURSTRING; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	020242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a subtotal colectomy, after using the purse string suture device for proximal section of the colon, the circular stapler was the inserted and fired.Before removing the stapler, the anastomosis was inspected and a hole was found in the proximal end.Upon checking the 'donuts', the distal donut was complete, the proximal donut with the purse string suture was not complete where the hole had appeared.The doctor then sutured the hole in the anastomosis, then gave the patient a temporary stoma to allow the anastomosis time to heal.The surgical time was extended by one hour due to the issue.
Additional Manufacturer Narrative
D10 concomitant product: trieea28mt, cir stplr trieea28mt medthk wt, (lot #p3m0912).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the pushers were fully deployed.Cartridges were properly seated after firing.No visual abnormalities.It was reported that during a subtotal colectomy, after using the purse string suture device for proximal section of the colon, the circular stapler was inserted and fired.Before removing the stapler the anastomosis was inspected and a hole was found in the proximal end.Upon checking the "donuts", the distal donut was complete, the proximal donut with the purse string suture was not complete where the hole had appeared.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PURSTRING
• Common Device Name: CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20359081
• Report Number: 2647580-2024-04276
• Device Sequence Number: 8127220
• Product Code: GDJ
• UDI-Device Identifier: 10884521051430
• UDI-Public: 10884521051430
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K901107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: 020242
• Device Catalogue Number: 020242
• Device Lot Number: P3E0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown