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

Model Number	ONB5STF
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: onb5stf, onb5stf versaone opt 5mm std trocar, (lot# unknown).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.
Event or Problem Description
According to the reporter, in a laparoscopic adnexectomy, the seal of two trocars were damaged.A ct (computed tomography) scan after the surgery revealed that there were metal fragments inside the body.The fragments have a round shape of about 3 mm.
Additional Manufacturer Narrative
Additional information: h6 information received shows that this event is a duplicate of another issue reported under regulatory report #.This file will be closed and all further updates processed under the above-referenced report for this event.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21292162
• Report Number: 9612501-2025-00321
• Device Sequence Number: 7585896
• Product Code: GCJ
• UDI-Device Identifier: 10884521134232
• UDI-Public: 10884521134232
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112349
• 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,Followup
• Report Date (Section B): 02/10/2025

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: ONB5STF
• Device Catalogue Number: ONB5STF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown