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

Model Number	CL-812
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	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an abdominoplasty, with liposuction, fat transfer to the gluteal area, mastopexy with implants, fleur-de-lis, and brachioplasty, while using the device during muscle application, the needle separated from the suture strand while suturing.The needle did not fall into the patient's cavity.The doctor refused other alternatives and, since there was no other lot number of the same type, sutures were used until one was found that did not detach.A total of ten sutures had the same issue.It was noted that the time was extended by more than 30 minutes due to the issue.
Additional Manufacturer Narrative
D10.Concomitant products: cl-812, cl-812 polysorb* 0 vio 75cm gs21 x36 (lot: a5d1596y); cl-812, cl-812 polysorb* 0 vio 75cm gs21 x36 (lot: a5d1596y); cl-812, cl-812 polysorb* 0 vio 75cm gs21 x36 (lot: a5d1596y); cl-812, cl-812 polysorb* 0 vio 75cm gs21 x36 (lot: a5d1596y); cl-812, cl-812 polysorb* 0 vio 75cm gs21 x36 (lot: a5d1596y); cl-812, cl-812 polysorb* 0 vio 75cm gs21 x36 (lot: a5d1596y); cl-812, cl-812 polysorb* 0 vio 75cm gs21 x36 (lot: a5d1596y); cl-812, cl-812 polysorb* 0 vio 75cm gs21 x36 (lot: a5d1596y); cl-812, cl-812 polysorb* 0 vio 75cm gs21 x36 (lot: a5d1596y).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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the submitted photo depicted one needle and one partial suture.The needle was observed to be detached from the suture.The rest of the suture obscured from the frame of the image.It was reported that the needle separated from the suture strand.The reported issue was 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: 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: 23952542
• Report Number: 1219930-2026-00028
• Device Sequence Number: 12720205
• Product Code: GAM
• UDI-Device Identifier: 10884521049697
• UDI-Public: (01)10884521049697(17)300331(10)A5D1596Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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-812
• Device Catalogue Number: CL-812
• Device Lot Number: A5D1596Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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 H11.
• Patient Age: 48 YR
• Patient Sex: Female