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

Model Number	B12LGF
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during robotic appendectomy with hysterectomy procedure, at the time of the introduction of the robot optics, the surgeon felt difficulty due to malleability of the film not returning to the central positioning.The surgeon then used another device to resolve the issue in order to complete the case.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
• MDR Report Key: 11562494
• Report Number: 9612501-2021-00458
• Device Sequence Number: 4846070
• Product Code: GCJ
• UDI-Device Identifier: 10884521539891
• UDI-Public: 10884521539891
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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 Expiration Date: 07/31/2021
• Device Model Number: B12LGF
• Device Catalogue Number: B12LGF
• Device Lot Number: J6G1302X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1