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

Catalog Number	60-6085-201
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 60-6085-201, vcare medium (34mm) cup, was returned to the quality assurance complaint laboratory regarding a complaint of "a piece of the balloon broke inside the patient's abdomen." visual inspection by subject matter experts, including the manufacturing engineer and manufacturing quality engineer, found the product device to have a damaged or breached uterine balloon which appears to be use related damage.The fragment of the balloon was received in a sealed blue container.The uterine balloon breach and fragment were both measured to be between approximately 9 and 10 mm in length.This complaint for balloon breakage is confirmed.A review of the manufacturing documents from the dhr/lhr 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 this reported incident has been escalated to the capa system per capa id (b)(4).To reduce the risk of patient injury, the instructions for use (ifu) 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 to conmed on medwatch uf # (b)(4), "during a robotic assisted hysterectomy, the uterine manipulator was placed on the cervix prior to incision into the abdomen.After incision into the abdomen, during the procedure, an object resembling a contact lens was observed in the abdomen.It was then noted that a piece of the balloon (the same size and light blue color) was missing from the uterine manipulator.The broken piece was retrieved from the patient's abdomen." follow up with the user facility found there was no delay in the procedure and no patient injury.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: 6535335
• Report Number: 1320894-2017-00098
• Device Sequence Number: 978395
• Product Code: LKF
• UDI-Device Identifier: 00653405061802
• UDI-Public: (01)00653405061802(17)180801(30)1(10)201608011
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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: 08/01/2018
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 201608011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 05/01/2017
• 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: 62 YR
• Patient Weight: 62