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

Model Number	RONB11STF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: mrasi0001, monopolar curved shears mrasi0001 (serial (b)(6)), mrasi0004, bipolar fenestrated grasper mrasi0004 (serial (b)(6)), mrasc0002, arm cart assembly mrasc0002 (serail (b)(6)), mrasc0002 arm cart assembly mrasc0002 (serial(b)(6)).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 robotic laparoscopic trans obturator tape removal and fix of fascia lata sling, there were multiple issues.First, during docking, the robotic trocar was burped to create some space inside the cavity and the head of the trocar broke and was replaced with a new one.Later, during the cutting of tissues, the surgeon made a fast cutting movement with the monopolar curved shears (mcs) and an error occurred.The mcs was removed by the scrub nurse following the official medtronic broken instrument quick reference guide.The instrument was replaced with a new one.While the instrument was removed, an error occurred on arm cart assembly (aca) #2.The aca was restarted because it was not responding.After the restart and successful calibration, the new mcs was attached.During the coagulation of the tissue, the bipolar fenestrated grasper (bfg) cable broke with a pulley device falling into the cavity.The bfg was removed by the scrub nurse following the official medtronic broken instrument quick reference guide.The instrument was replaced with a new one.While the instrument was removed, an error occurred on arm cart assembly (aca) #1.The aca was restarted because it was not responding.After the restart and successful calibration, the new bfg was attached.All of the issues created a delay of 20-30 minutes.There was no patient injury.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19686842
• Report Number: 9612501-2024-01657
• Device Sequence Number: 12792822
• Product Code: GCJ
• UDI-Device Identifier: 10884521717688
• UDI-Public: 10884521717688
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 07/07/2024

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: RONB11STF
• Device Catalogue Number: RONB11STF
• 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: 06/11/2024
• Initial Report FDA Received Date: 07/07/2024
• 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
• Patient Sex: Female