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

Model Number 60-6085-201A

Device Problem Detachment Of Device Component (1104)

Patient Problem Uterine Perforation (2121)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

Conmed was unable to evaluate the device as it was discarded by user facility; therefore, the reported detachment of the device component is unable to be verified.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.The products released for distribution were found to have met all specifications prior to shipment.In this lot of (b)(4) units, this is the only complaint against this lot.A 2-year product history review revealed a total of 2 complaints for this device and failure mode combination.In that same timeframe (b)(4) units have been sold worldwide making the occurrence rate for this reported failure mode (b)(4).Based on this information this failure is acceptable when weighed against the benefits of use of this device.The instruction for use advice the user of the following when using this device: visually inspect vcare on removal from the patient to verify that the device is intact and all forward components have all been retrieved from the patient.Should uterine perforation and/or bleeding occur immediately follow the clinically indicated procedure to establish hemostasis.Improper use of this or any intrauterine instrument can result in perforation of the uterine wall and subsequent bleeding.This incident has been escalated and will be investigated further due to the reported patient injury.

Event Description

A conmed sales representative reported on behalf of a user facility that during the colpotomy portion of a robotic assisted total hysterectomy, the handle of the vcare became detached from the shaft while rotating the device left to right.This alleged device malfunction caused the surgical assistant to push the device forward more than intended, which led to a perforated uterus.Additionally, the user facility reported no delays in procedure and the perforation caused minimal bleeding that was resolved with cauterization.The complaint device was discarded and will not be returned for evaluation.This report is being raised on the basis of an alleged device malfunction which caused a patient injury.

• Brand Name: VCARE MEDIUM (34MM) 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: 6785468
• MDR Text Key: 82401517
• Report Number: 1320894-2017-00177
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)190123(10)201701231
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2017

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?: Yes
• Device Operator: Other
• Device Expiration Date: 01/23/2019
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201701231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 89