MAUDE Adverse Event Report: CONMED CORPORATION VCARE MEDIUM; RETRACTOR-ELEVATOR, VAGINAL-CERVICAL AHLUWALIA

Catalog Number 60-6085-201A

Device Problem Inflation Problem (1310)

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

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

The following elements have blank data.

Event Description

A vcare medium device was given to the surgeon to be tested before use.The balloon would not inflate upon testing, so the device was removed from the sterile field and a new one was introduced.The same error occurred with the second device.A third device was successfully used and the procedure was completed with no harm to the patient.The second device was also removed from the sterile field and both were sent to the clinical engineering department.It was noted that the two failed devices were of the same lot.The device will be returned to the manufacturer for failure analysis and replacement.Hospital will share manufacturer test/evaluation results with medsun.

• Brand Name: VCARE MEDIUM
• Type of Device: RETRACTOR-ELEVATOR, VAGINAL-CERVICAL AHLUWALIA
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 6518434
• MDR Text Key: 73594763
• Report Number: 6518434
• 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: 04/20/2017,04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/13/2019
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201702131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 78