MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	170056
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a hysterectomy, the needles of nine sutures broke off.The device was replaced.There no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: 170056, 170056 endo stitch 0 und 120 polysbx12, (lot number: j2l3091y); 170056, 170056 endo stitch 0 und 120 polysbx12, (lot number: j2l3091y); 170056, 170056 endo stitch 0 und 120 polysbx12, (lot number: j2l3091y); unknown estitch,unknown endo stitch instrument, (lot number: unknown); 170056, 170056 endo stitch 0 und 120 polysbx12, (lot number: j4g2563y); 170056, 170056 endo stitch 0 und 120 polysbx12, (lot number: j4g2563y); 170056, 170056 endo stitch 0 und 120 polysbx12, (lot number: j4g2563y); 170056, 170056 endo stitch 0 und 120 polysbx12, (lot number: j4g2563y); 170056, 170056 endo stitch 0 und 120 polysbx12, (lot number: j4g2563y).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.

• Brand Name: POLYSORB
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25617883
• Report Number: 9612501-2026-01721
• Device Sequence Number: 21365983
• Product Code: OCW
• UDI-Device Identifier: 20884521126579
• UDI-Public: (01)20884521126579(17)290630(10)J4G2563Y(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: 170056
• Device Catalogue Number: 170056
• Device Lot Number: J4G2563Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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: Unknown