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

Catalog Number 60-6085-201

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2014

Event Type  malfunction  

Event Description

Hole in balloon from manufacturer.Problem identified before the device was used on the patient.Packaging was intact.Suspect hole was present prior to opening package.Failed device did not reach the patient.
=
manufacturer response for vcare uterine manipulator, medium, vcare uterine manipulator, medium (per site reporter)
=
manufacturer provided return ship kit for failed device and provided new replacement device.

• Brand Name: VCARE MEDIUM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORP; 525 french road; utica NY 13502
• MDR Report Key: 3711947
• MDR Text Key: 4251148
• Report Number: 3711947
• Device Sequence Number: 1
• Product Code: LKF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 130905 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1