MAUDE Adverse Event Report: COVIDIEN PURSTRING; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	020730
Medical Device Problem Codes	Material Frayed (1262); Misfire (2532); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a procedure, there was a problem with the firing.A new device was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during a procedure, there was a problem with the firing and the thread was tangled and frayed.A new device was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.H3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.It was reported that there was a problem with the firing and the thread was tangled and frayed.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition of disengaged cartridge and suture.The product analysis noted evidence that the device was not used as intended.This issue may occur when contact is made when excessive force is applied during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: when closing the instrument jaws, the ring handles must be squeezed until they lock together.Failure to lock the handles may result in improperly formed staples.Improperly formed staples may compromise the integrity of the purse-string closure.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): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22283440
• Report Number: 2647580-2025-01880
• Device Sequence Number: 8819815
• Product Code: GDJ
• UDI-Device Identifier: 10884521051478
• UDI-Public: 10884521051478
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K901107
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 020730
• Device Catalogue Number: 020730
• Device Lot Number: P4D0997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown