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

Model Number	ONB12STF
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 - concomitant products: egia60amt, egia60amt egia 60 artic med thick sulu, (lot# p5c1346); sigphandle, sig power sigphandle handle, (s#unknown); sigadaptstnd, sig power sigadaptstnd linear adapter, (s#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.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
It was reported that during a laparoscopic gastric bypass surgery, the reload locked on tissue and could not be removed during the second stapling upon returning the blade.All instructions to unlock the load were followed, including holding both side buttons to restart, removing and reconnecting the rod, and using the key to disarticulate and open the device, but these actions were unsuccessful.The surgeon manually removed the tissue and performed sub-suturing and staple line reinforcement to resolve the issue.The trocar experienced a valve break, causing a leak, and the lens disengaged.The trocar was replaced.
Additional Manufacturer Narrative
Additional information: b5, g3.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
It was reported that during a laparoscopic gastric bypass surgery, the load stapled correctly without problems, however the reload locked on tissue and could not be removed.During the second stapling, when it went through the fabric, there was difficulty in retracting the knife blade.All instructions to unlock the load were followed, including holding both side buttons to restart, removing and reconnecting the rod, and using the key to disarticulate and open the device, but these actions were unsuccessful.The surgeon manually removed the tissue and performed sub-suturing and staple line reinforcement to resolve the issue.The trocar experienced a valve break, causing a leak, and the lens disengaged.The trocar was replaced.

• 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: 24319671
• Report Number: 9612501-2026-00344
• Device Sequence Number: 15990890
• Product Code: GCJ
• UDI-Device Identifier: 10884521657687
• UDI-Public: (01)10884521657687(17)300531(10)J5F2540Y
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: ONB12STF
• Device Catalogue Number: ONB12STF
• Device Lot Number: J5F2540Y
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/24/2026
• Date Device Manufactured: 06/09/2025
• 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 Sex: Female