MAUDE Adverse Event Report: CONMED CORPORATION VCARE MEDIUM (34MM) CUP; UTERINE MANIPULATOR

Catalog Number	60-6085-201
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One (1) 60-6085-201 vcare medium (34mm) cup was returned to the conmed quality assurance lab.Visual inspection of the device found the cervical cup and intrauterine balloon had completely detached from the manipulator tube.Therefore, this complaint was confirmed.It was noted that the locking mechanism was firmly attached to the manipulator tube, indicating that it had not been released when removed.No manufacturing or part related defect was identified upon examination.The production line was reviewed and no issues were identified.A review of the manufacturing documents from the device history record/lot 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.This failure is addressed in the risk documents.To date there have been no long term adverse effects resulting from this type of incident, however, there is currently a capa initiated to address this reported issue.To reduce the risk of patient injury, the instructions for use (ifu) states: "prior to device removal, 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." the ifu further states: "upon removing vcare, the surgeon should visually inspect the vcare device, and the patient, to make sure that no components or fragments of these components were retained in the patient.There are 5 parts/components to the vcare cervical elevator retractor.These are: 1) the balloon; 2) the forward "cervical" cup; 3) the back or vaginal cup; 4) the locking assembly with thumbscrew; 5) the metal shaft and handle with balloon inflation valve.".
Event or Problem Description
As reported on medwatch form user facility # (b)(4), during a total laparoscopic hysterectomy, "the 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." there was no significant delay in procedure or injury to the patient.This report is filed on the basis of potential injury with recurrence.

• Brand Name: VCARE MEDIUM (34MM) CUP
• Common Device Name: UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6591580
• Report Number: 1320894-2017-00111
• Device Sequence Number: 16224332
• Product Code: LKF
• UDI-Device Identifier: 00653405061802
• UDI-Public: (01)00653405061802(17)180620(30)1(10)201606201
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2018
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 201606201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 171