MAUDE Adverse Event Report: CONMED CORPORATION VCARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number 60-6085-200A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2017

Event Type  malfunction  

Event Description

During laparoscopic hysterectomy, as the surgeon cut into the cervix, there were two small pieces of vcare noted.No patient harm.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 7013450
• MDR Text Key: 91501233
• Report Number: 7013450
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 201610191
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SURGICAL ROBOT (DAVINCI)
• Patient Age: 61 YR