MAUDE Adverse Event Report: CONMED CORPORATION VCARE,SMALL (31MM) CUP

Catalog Number 60-6085-200

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

Based on the user facilities order history since a product code and lot were not provided, product code 60-6085-200 was chosen to allow visibility for trending purposes.An evaluation was unable to be performed as the device was not returned.This device malfunction did not cause or contribute to any adverse patient reactions or effects.The patient is currently recovering well.A historical review of complaint data for this product family revealed 28 similar complaints have been received in the past two years.In that same timeframe, (b)(4) vcare devices have been sold worldwide, making the occurrence rate of this failure (b)(4).Due to the unknown device information, a review of the manufacturing documents was not possible.The instructions for use advise the user of the following for the removal process of the vcare device.- prior to removal of the device, 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.-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.-there are 5 parts/components to the vcare cervical elevator retractor.These are: the balloon; the forward "cervical" cup; the back or vaginal cup; the locking assembly with thumbscrew; the metal shaft and handle with balloon inflation valve.This reported issue will continue to be monitored through the complaint system.

Event Description

The user facility filed report number mw5071087 on (b)(6)2017.Conmed received this report on 2017-08-04.The initial report stated a female patient underwent a diagnostic laparoscopy.The procedure was converted to an exploratory laparoscopy and then an exploratory laparotomy for a total abdominal hysterectomy and salpingo-oophorectomy.The vcare device was used and once the procedure was converted, it was removed.Since the case was initially a laparoscopy hysterectomy, the vcare uterine manipulator was used and then removed when the operating approach changed.The device was removed and set aside but not examined to assure it was intact.The procedure was completed successfully.During the patient's port-operative visit, she was feeling well and stated no complaints of pain or discomfort.A vaginal exam was not performed.Months later the patient underwent chemotherapy and was being evaluated for possible radiation treatment when a green foreign body was observed in the vaginal canal.An ob/gyn was contacted to examine the patient and confirmed the presence of the vcare green colpotomy ring in the vaginal canal.It was removed and the vaginal canal and cuff were noted to be intact.Additional information from the user facility has since been collected.The specific product code and lot number are unknown and the intact green cervical cup will not be returned for evaluation.A week after the component was found and removed from the vaginal canal, the patient was seen for a follow-up appointment.It was noted she was recovering well and antibiotics were not prescribed.The report is raised as a potential serious injury due to a component not being initially retrieved upon the reported device malfunction.

• Brand Name: VCARE,SMALL (31MM) 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: 6806152
• MDR Text Key: 83097363
• Report Number: 1320894-2017-00183
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2017

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: Health Professional
• Device Catalogue Number: 60-6085-200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Weight: 77