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

Catalog Number 60-6085-201A

Device Problems Component Falling (1105); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/04/2017

Event Type  malfunction  

Event Description

Patient scheduled for a uterovaginal repair.Procedure done was a robotic hysterectomy, bilateral salpingo-oophorectomy and lysis of adhesions.Patient positioned in dorsal lithotomy position.She was prepped and draped in normal sterile fashion.Foley catheter was placed under sterile conditions.Speculum was placed in the vagina and cervix grasped with a single-tooth tenaculum.In the cervix, a 0 vicryl was placed at 3 and 9 o'clock position.The v-care manipulator medium was secured to the cervix using this and then engaged in the vagina according to manufacturer's instructions.An 8 mm incision was made at the umbilicus and a veress needle was placed.The abdomen was insufflated with carbon dioxide gas.An 8 mm robotic port was placed under direct visualization.We then placed 2 ports, 9 and 18 cm right of midline and two 9 and 18 cm left of midline.Correction, that the most lateral port on the right side was the assistant port, an 11 mm port.The patient had been placed in trendelenburg.She had significant adhesions in the right lower quadrant from her prior surgery.These were taken down.Then, the intestine was able to pass into the patient's upper abdomen.The right round ligament was divided.The retroperitoneal space was opened and the ureter was identified on the right side.The gonadal vessels were isolated.They were divided and secured proximally with hem-o-lok clips.The utero-ovarian ligament was taken to the uterus.The vesicouterine peritoneum was taken down.The uterine vessels were cauterized.On the left, the round ligament was divided, retroperitoneal space opened and the ureter was identified.Gonadal vessels were divided and secured proximally with hem-o-lok clips and the broad ligament was taken to the utero-ovarian ligament.The vesicouterine peritoneum was divided and reflected off of the lower uterine segment and vagina.The uterine vessels were cauterized on the left and then divided.The cardinal ligaments were taken in successive pedicles and then the uterosacral ligaments.On the right side, we divided the uterine, the cardinals, and the uterosacral.When we were dividing the uterosacral on the left side, the harmonic went a little deeper and engaged the vcare cup.A small fleck of this came off.This was grasped to be removed from the patient's abdomen, but it fell out of the jaws of as we were trying to bring it through the trocar.We were unable to relocate it.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 6837763
• MDR Text Key: 84425560
• Report Number: 6837763
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/06/2019
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201703061
• Other Device ID Number: 17681 C U303
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; YES, SURGEON WAS USING THE HARMONIC SCALPEL THAT C
• Patient Age: 68 YR
• Patient Weight: 59