MAUDE Adverse Event Report: CONMED CORP. V-CARE MANIPULATOR

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/04/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017, the (b)(6) female patient underwent a diagnostic laparoscopy which was converted to exploratory laparoscopy which was converted to exploratory laparotomy, total abdominal hysterectomy, salpingo-oophorectomy.Since the case was planned initially as a laparoscopy hysterectomy, the v-care uterine manipulator was placed in the uterus as usual, when the decision was made to convert to laparotomy, the v-care manipulator was removed from the uterus.During the removal, the tip of the manipulator apparently broke and stayed inside the vaginal canal along with a "green colpotomy ring" which went unnoticed.The surgical procedure proceeded well, and the patient had no post-operative complaints.During her post-operative visit on (b)(6) 2017, she was feeling well, had no complaints and no vaginal examination was performed.She was undergoing chemotherapy recently and was being evaluated on (b)(6) 2017 for possible radiation.During examination, a green foreign object was noted in the vagina.Ob/gyn was contacted.On exam, the presence of the v-care colpotomy ring in the vagina was confirmed.It was removed and the vaginal canal and cuff was otherwise intact.

• Brand Name: V-CARE MANIPULATOR
• Type of Device: V-CARE MANIPULATOR
• Manufacturer (Section D): CONMED CORP.
• MDR Report Key: 6724637
• MDR Text Key: 80558496
• Report Number: MW5071087
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 77