MAUDE Adverse Event Report: CONMED CORPORATION VCARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number 60-6085-201A

Device Problem Material Separation (1562)

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

Event Date 10/04/2018

Event Type  malfunction  

Event Description

V-care was attached to cervix.While attempting to get large uterus and cervix out vaginally the v-care fell apart.The green section and balloon were inside but successfully taken out.All pieces accounted for.Surgeon notified.Procedural note:.A medium v-care uterine manipulator was inserted into the uterus.The vascular pedicles were then mobilized laterally off of the cervix.A circumferential colpotomy was performed along the v-care ring.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 8013633
• MDR Text Key: 125286715
• Report Number: 8013633
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 10653405003793
• UDI-Public: (01)10653405003793(17)200514(10)201805151
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201805151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 102