MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAONE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	BPT12STS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Laceration(s) (1946); Unintended Radiation Exposure (4565)
Date of Event	05/16/2026
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 laparoscopic appendectomy, the inner end of the cannula broke inside the abdomen.The surgery was converted to an open procedure, and an x-ray was performed but the broken cannula was not detected.On (b)(6) 2026, the patient had a computed tomography scan, but there was no fragment found.The surgical time was extended by two hours to find the fragment and hospitalization was extended by three more days in order to determine the possible visualization of the trocar fragment in the abdomen, although the patient appeared to be in good condition.

• Brand Name: VERSAONE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 25332741
• Report Number: 9612501-2026-01487
• Device Sequence Number: 21302573
• Product Code: GCJ
• UDI-Device Identifier: 20884521621050
• UDI-Public: (01)20884521621050(17)301130(10)J5M3395DY
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K142547
• 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
• Report Date (Section B): 05/29/2026

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: BPT12STS
• Device Catalogue Number: BPT12STS
• Device Lot Number: J5M3395DY
• 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: 05/20/2026
• Initial Report FDA Received Date: 05/29/2026
• Date Device Manufactured: 12/29/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Unknown