MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN

Model Number	VP-761-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	11/10/2025
Type of Reportable Event	Serious 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 cardiac surgery, the scrub nurse discovered that the tip of the non-absorbable monofilament polypropylene suture was missing a 1 x 0.5 mm fragment while collecting needles.The surgical team was immediately notified to begin searching, and the operating room supervisor, head nurse, and chief of cardiovascular surgery were informed.Additional personnel were dispatched to assist with the search.The scrub nurse and surgical team, while ensuring patient safety, carefully inspected and used a needle finder to examine the operating table, instrument table, sterile abdominal drapes, surgical field and incision area, and inside the incision.The circulating nurse used a needle finder to thoroughly inspect the operating room floor, under the surgical bed, surfaces of instruments and equipment, the clothing and shoe soles of the surgical team, and every corner of the operating room.All gauze, suction bottles, and garbage bags were searched with no findings.C-arm fluoroscopy of the surgical field and the blood recovery container revealed no suspicious needle tip images.After consulting the surgeon, the breakage may have occurred when the needle tip was being clamped.

• Brand Name: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN
• 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: 23788452
• Report Number: 9612501-2025-03325
• Device Sequence Number: 10477198
• Product Code: GAW
• UDI-Device Identifier: 10884521039148
• UDI-Public: (01)10884521039148(17)290630(10)D4G4398GY(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VP-761-X
• Device Catalogue Number: VP-761-X
• Device Lot Number: D4G4398GY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 07/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male