MAUDE Adverse Event Report: CONMED CORP V-CARE UTERINE MANIPULATOR; CERVICAL CUP

Model Number V CARE-SMALL

Device Problem Torn Material (3024)

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

Event Date 03/18/2014

Event Type  No Answer Provided  

Event Description

During an lap abdominal hysterectomy the v-care device separated when the balloon deflated.As they were trying to retrieve the specimen the cone/cup that is positioned next to the cervix slid over the balloon and tore a portion of the balloon.All pieces were retrieved from the pt this time.This is the second incidence with the v-care and the other resulted in an unintended retention of a foreign object (the cone/cup).

• Brand Name: V-CARE UTERINE MANIPULATOR
• Type of Device: CERVICAL CUP
• Manufacturer (Section D): CONMED CORP; utica NY 13502
• MDR Report Key: 3709419
• MDR Text Key: 4236467
• Report Number: MW5035282
• Device Sequence Number: 1
• Product Code: LKF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: V CARE-SMALL
• Device Catalogue Number: REF 60-6085-200
• Device Lot Number: 130401 1
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 114