MAUDE Adverse Event Report: CONMED CORPORATION V-CARE VAGINAL-CERVICAL-AHLUWALIA'S RETRACTOR-ELEVATOR; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Lot Number 201606201

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2016

Event Type  malfunction  

Event Description

V-care uterine manipulation device balloon and green cup detached from handle inside patient.All detached parts were recovered and the patient was not harmed.

• Brand Name: V-CARE VAGINAL-CERVICAL-AHLUWALIA'S RETRACTOR-ELEVATOR
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 6544326
• MDR Text Key: 74431156
• Report Number: 6544326
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/20/2018
• Device Lot Number: 201606201
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2017
• 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: 51 YR