MAUDE Adverse Event Report: CONMED CORPORATION VCARE LARGE (37MM) CUP

Catalog Number 60-6085-202

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

The reported device was not returned to conmed for evaluation as it was discarded by the user facility.This complaint is confirmed, however, on the basis of the submitted photo.The device components have clearly detached from the device itself.A review of the manufacturing documents from the device history record has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.There have been no additional complaints reported against this lot of (b)(4) units.A two-year review of complaint history revealed 28 similar complaints have been reported for the reported issue of "cup detachment".(b)(4).A risk analysis was performed and it was found to be acceptable.The instructions for use advise the user of the following.-prior to removal of the device, ensure the locking mechanism is released via the thumbscrew and swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.-do not use excessive force upon device removal to avoid traumatizing the vaginal canal and/or component detachment.-vaginal delivery of a large uterus may result in patient injury.Methods should be used to reduce the size of the uterus prior to removal through the vaginal canal.-upon removing vcare, the surgeon should visually inspect the vcare device, and the patient, to make sure that the entire vcare device was properly removed and that no components or fragments of these components were retained in the patient.There are 5 parts/components to the vcare cervical elevator retractor.The balloon.The forward "cervical" cup, the back or vaginal cup, the locking assembly with thumbscrew, the metal shaft and handle with balloon inflation valve.An investigation is currently opened to determine the root cause of this reported issue.All complaints associated with this product will continue to be monitored through the complaint system.

Event Description

A user facility reported a 60-6085-202 vcare device dropped to bits.The device components were reported to detach from one another but the uterus and upper cup stayed connected.Despite several attempts to collect additional information regarding the term "dropped to bits", no clarification has been provided.The procedure was completed as planned.No patient injury was reported and all detached components were retrieved.This device was discarded by the user facility; therefore, a specific failure mode/root cause is unable to be determined.Although the complaint is unable to be verified/confirmed, photos show the device in multiple pieces.The cervical cup and vaginal cone has completely detached from the manipulator tube.The report is raised on the basis of a device malfunction with potential for injury if recurrence.

• Brand Name: VCARE LARGE (37MM) CUP
• Type of Device: VCARE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502-5994 ; 7273995209
• MDR Report Key: 6758142
• MDR Text Key: 81958830
• Report Number: 1320894-2017-00169
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 00653405061819
• UDI-Public: (01)00653405061819(17)181128(30)1(10)201611281
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Catalogue Number: 60-6085-202
• Device Lot Number: 201611281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR