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

Model Number	BPT12STS
Medical Device Problem Codes	Leak/Splash (1354); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during clinical, during uterolysis with excision of endometriosis when the port was placed on the 11mm adapter, it resulted in a rapid loss of pneumoperitoneum and inability to maintain the it.The surgeon tried multiple techniques for trouble shooting including changing insufflation equipment to air seal (which provides more rapid replacement of pneumoperitoneum to match losses), wrapping the trocar with gauze to improve the fit between adapter designed for 12 mm standard trocar and the 11 mm robotic trocar but it moved through the gas quickly.The 11mm trocar being incompatible without adjustment.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: ronb11stf ronb11stf postion v2 bldles opt 11m std - (lot#j5b3400y) 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: 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: 23831996
• Report Number: 9612501-2025-03381
• Device Sequence Number: 5093957
• Product Code: GCJ
• UDI-Device Identifier: 20884521621050
• UDI-Public: (01)20884521621050(17)300131(10)J5B3232DY
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: BPT12STS
• Device Catalogue Number: BPT12STS
• Device Lot Number: J5B3232DY
• 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: 11/21/2025
• Initial Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 02/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White