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

Model Number	UNVCA12STF
Medical Device Problem Codes	Melted (1385); Environmental Particulates (2930)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparoscopic surgical procedure, at the beginning of the surgery and during the laparoscopy process using the energy platform and a non-medtronic monopolar spatula, the energy was initially set at 20w for pure cut and coagulation and was then increased to 30w due to insufficient tissue effect, after which a match-sized flame occurred at the non-medtronic monopolar instrument upon activation via the monopolar foot switch.The device also caught on fire.The monopolar instrument was immediately withdrawn from the patient¿s cavity and discontinued, and a device was introduced; upon activating device energy inside the patient¿s cavity, an energy overload was reported and thermal damage (burning) to the surgical cannula occurred.The device was activated multiple times in succession just prior to the burn.An exploratory laparoscopic inspection of the abdominal cavity identified thermal lesions (burn) on the abdominal wall with associated tissue damage or unexpected tissue loss, and melted polymer debris inside the abdominal cavity that was reported to originate from the structurally compromised cannula.The burn was located around the trocar and in a region of the small intestine.Presence of melted polymer debris fell inside the cavity, originating from the structurally compromised cannula, but it was fully retrieved.Due to these complications and to ensure patient safety, the surgical team converted the procedure from laparoscopic to open surgery to retrieve the melted polymer debris from the patient and to check and treat the burn and assess the abdominal wall.There was no additional medical procedure needed to remove the melted polymer debris from the patient.Another device was used with the same generator and it worked fine.The event was reported to have led to extended hospitalization, and the patient was reported as alive with temporary injury and still recovering in the hospital.
Additional Manufacturer Narrative
D10 concomitant product: vlft10gen, vlft10gen ft series energy platformx1 (serial#: (b)(6); lf1937, jaw lap lf1937 ligasure maryland 37cm (lot#: 52680133x); unknown footswi, unknown footswitch (lot#: unknown); onb12stf, onb12stf versaone opt 12 std trocar (lot#: j5l3611y).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: VERSAPORT
• 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: 24925167
• Report Number: 9612501-2026-01101
• Device Sequence Number: 13331177
• Product Code: GCJ
• UDI-Device Identifier: 10884521215399
• UDI-Public: (01)10884521215399(17)290331(10)J4D3328Y
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K130435
• 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
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: UNVCA12STF
• Device Catalogue Number: UNVCA12STF
• Device Lot Number: J4D3328Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2026
• Initial Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 04/12/2024
• 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: PLEASE SEE NOTE ON H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown