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

Catalog Number 60-6085-202A

Device Problem Break (1069)

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

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.

Event Description

The conmed representative reported on behalf of the user facility that during a hysterectomy, the vcare handle broke while trying to manipulate the uterus from left to right.The handle did not completely break off.The procedure was completed with no reported procedural delays or patient injury.This report is raised on the basis of a reported malfunction.Historically, a break and detachment of the vcare handle has led to patient injury; therefore, the recurrence of this malfunction has the potential for injury.

Manufacturer Narrative

Device returned for evaluation on 16feb2018.Change from "not returned to manufacturer" to "yes" and "evaluation summary attached".(b)(4).The device was received with original opened product packaging.Visual inspection found the device's handle rotates independently from the vcare tube.The handle's casing was removed and it was observed that the vcare tube molding had fractured.The device's cervical cup was noted to be oblong, appearing deformed potentially from excessive pressure applied to the device.The reported issue was verified and a likely cause to contribute to this failure is operational technique.

Manufacturer Narrative

(b)(4).Manufacturer narrative: to date, the device has not been returned to conmed, therefore; it is unable to be evaluated.The reported failure could not be verified and a root cause cannot be determined.A review of the manufacturing documents verified the device was 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.A two-year review of complaint history revealed 4 other similar complaints for this product family and failure mode.During this same time frame, 243,368 devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure 0.002 percent.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.Remove vcare from its sterile packaging and inspect for damage caused by shipping.Discard if any damage is noted.This issue will continue to be monitored through the complaint system to assure patient safety.

• 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: martha camacho urribarri ; 525 french road; utica, NY 13502 ; 3156243051
• MDR Report Key: 7119092
• MDR Text Key: 95770728
• Report Number: 1320894-2017-00283
• Device Sequence Number: 1
• Product Code: LKF
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2019
• Device Catalogue Number: 60-6085-202A
• Device Lot Number: 201708091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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