MAUDE Adverse Event Report: COVIDIEN SURGICAL POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	CL-803
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: cl-803 polysorb* 1 vio 75cm gs24 x36 (lot# a5g1541y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot# a5g1541y) cl-803 polysorb* 1 vio 75cm gs24 x36 (lot# a5g1541y).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
It was reported that pre-operatively, while preparing the suture after patient incision, the needle detached from the suture.Four sutures were used and had the same issue.The issue was resolved by using a different lot.There was no patient involved.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 correction: a1 h3 evaluation summary: medtronic conducted an investigation based upon all information received.Thirty-one representative samples were available for evalu ation.Visual inspection noted varying degrees of discoloration (dark color) and suture stiffness were noted near the needle attachment point of the sutures.Functional testing noted that the breathable pouches were opened without any tears of the tyvek packaging.The sutures were removed from the retainers without any difficulty.The sutures were loaded onto a machine by clamping the needle with a pneumatic grip with a serrated face and the suture end with a pneumatic yarn grip.No suture breakage or fraying was noted while handling or loading the sutures into the machine.The machine then pulled the sutures until the needle disengaged from the sutures.The load force at the point of detachment was measured and the results were found to meet the mean and individual specifications.In addition to testing against the specifications, the samples were subjected to testing of the needle attachment force at 90° (degrees) of rotation.Results demonstrated lower forces than are typical for 90° attachment forces of this size suture.It was reported that the needle detached from the suture.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.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: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24669358
• Report Number: 1219930-2026-01880
• Device Sequence Number: 13068171
• Product Code: GAM
• UDI-Device Identifier: 10884521041868
• UDI-Public: (01)10884521041868(17)300630(10)A5G1541Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: CL-803
• Device Catalogue Number: CL-803
• Device Lot Number: A5G1541Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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 NOTE ON H11
• Patient Sex: Unknown