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

Model Number	VS101015P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
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, the surgeon found two small pieces from the cannula in the patient's cavity during robotic laparoscopic cystectomy.The two pieces were retrieved using grasper.There was no patient injury.

• Brand Name: MCGRATH
• 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: 12229697
• Report Number: 9612501-2021-01232
• Device Sequence Number: 1390817
• Product Code: GCJ
• UDI-Device Identifier: 10884521082847
• UDI-Public: 10884521082847
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K012539
• 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): 07/26/2021

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 Model Number: VS101015P
• Device Catalogue Number: VS101015P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1