MAUDE Adverse Event Report: CONMED CORPORATION VCARE, SMALL (32MM) CUP

Model Number 60-6085-200A

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to conmed for evaluation and no photographs were provided.Therefore, the reported failure cannot be verified and root cause cannot be determined without the examination of the actual device.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.A historical review of complaint data revealed a total of 8 similar complaints, of which 4 were confirmed, in the past two years.(b)(4).A risk analysis was performed and found this failure mode and occurrence level to be acceptable and consistent with current risk documents.The instructions for use advise the user of the following.- in laparoscopic supracervical hysterectomy, avoid contact between vcare and dissecting instruments during uterine dissection and excision to avoid risk of patient injury.Damage to vcare, including rupture of the intrauterine balloon, may occur.- swipe a finger around the edge of the vaginal cup to separate the tissue from the cup to prevent tissue damage.- 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The user facility reported that during a laparoscopic hysterectomy, as the surgeon cut into the cervix, two small pieces of vcare were noted.No patient injury was reported.Although multiple attempts have been made, no additional information has been provided such as current patient status and completion of procedure.This report is raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: VCARE, SMALL (32MM) 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: martha camacho urribarri ; 525 french road; utica, NY 13502-5994
• MDR Report Key: 6996810
• MDR Text Key: 91454554
• Report Number: 1320894-2017-00239
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003748
• UDI-Public: (01)10653405003748(17)181019(10)201610191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/19/2018
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 201610191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR