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

Model Number	CL-915
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: cl-915 cl-915 polysorb* 1 vio 90cm gs24 x36 - (lot#a5b1687y); cl-915 cl-915 polysorb* 1 vio 90cm gs24 x36 - (lot#a5b1687y); cp-415 cp-415 surgipro* 1 blu 90cm hgs22 x36 - (lot#d4d2475y); gl-223 gl-223 polysorb* 2-0 vio 75cm v30 x36 - (lot#a5f1757y); cl-915 cl-915 polysorb* 1 vio 90cm gs24 x36 - (lot#a5b1498y); cl-915 cl-915 polysorb* 1 vio 90cm gs24 x36 - (lot#a5b1498y); cl-915 cl-915 polysorb* 1 vio 90cm gs24 x36 - (lot#a5b1498y); cl-915 cl-915 polysorb* 1 vio 90cm gs24 x36 - (lot#a5b1498y); 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 during a myomectomy procedure, the needle bent.This occurred repeatedly across 34 sutures.Additionally, out of the 32 sutures, six sutures also had their thread detached from the swage point, while suturing or while preparing the suture after the patient's incision; the needle did not fall into the patient's cavity.It was reported that the surgery was interrupted multiple times due to the issues, and that an additional new suture was used without issue.It was noted that the surgical time was extended by more than 30 minutes due to the issue.
Event or Problem Description
It was reported that during a myomectomy procedure, the needle bent.This occurred repeatedly across 32 sutures.Additionally, out of the 32 sutures, six sutures also had their thread detached from the swage point, while suturing or while preparing the suture after the patient's incision; the needle did not fall into the patient's cavity.It was reported that the surgery was interrupted multiple times due to the issues, and that an additional new suture was used without issue.It was noted that the surgical time was extended by more than 30 minutes due to the issue.
Additional Manufacturer Narrative
Additional information: b5, g3 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: 25395072
• Report Number: 1219930-2026-03514
• Device Sequence Number: 21512363
• Product Code: GAM
• UDI-Device Identifier: 10884521043336
• UDI-Public: (01)10884521043336(17)300131(10)A5B1498Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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-915
• Device Catalogue Number: CL-915
• Device Lot Number: A5B1498Y
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 05/24/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 06/12/2026
• Date Device Manufactured: 02/19/2025
• 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 Sex: Female