Summary of MedSun Reports Describing Adverse Events With the ConMed VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) Uterine Manipulator
MedSun: Newsletter #32, January 2009
Over the past four months, MedSun has received nine adverse event reports associated with the VCARE device manufactured by ConMed Corporation, which resulted in a recall. The reports were submitted by three different hospitals between April 2008 and July 2008. The reported device problems include:
•Three balloon failures, with two of these reports also including retained portions of the device.
•Two cup malfunctions; one report of the cup breaking into pieces, and one report of the cup melting during the procedure.
•Two reports of the device breaking into pieces after placement.
•Two reports of the device resulting in uterine perforations.
The reported patient injuries include:
•One report of the retained portion of device removed in the physician’s office.
•One report of the retained portion of device resulting in pain and malodorous odor, with the patient admitted to the hospital for prophylactic antibiotic treatment.
•Two reports of uterine perforations; however, these patients were scheduled for laparoscopic hysterectomies. One case was converted to an open abdominal procedure.
The reported female patient age range was 34 years to 56 years old.
These MedSun reports contributed to FDA awareness of the device problems. FDA follow-up with the manufacturer resulted in a Class II Recall. The following recall, describing problems with the VCARE, are noted to be associated with the ConMed device.
On October 28, 2008, the VCARE was voluntarily recalled by the manufacturer because the firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
|Device||Device Identifiers||Event Description|
|ConMed/VCARE (Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator)||Catalog # 60-6085-100 Lot # 0803121 Standard||Surgeon had to manually extract V-care cup from the cervical os. Patient remained stable; no issues related to removing manipulator.|
|ConMed/VCARE (Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator)||Ref # 60-6085-100 Lot # 0803061 Standard||V-Care manipulator broke into pieces after procedure. The entire device was accounted for post-procedure. No Patient Harm. We have had prior problems with this device, and recently received additional in-service training from the manufacturer. During the training we did not identify any procedural issues that would explain the failures.|
|ConMed/VCARE (Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator)||Device Identifiers Unknown||The cup which was inserted into the cervix melted during the surgery. The physician stated that there was no harm to the patient as a result of this incident. A follow up in-service with the staff will take place regarding the operation of the ESU device.|
|ConMed/VCARE (Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator)||Device Identifiers Unknown||As the doctor was blowing up the balloon during removal of the device, it broke into pieces. There was no patient harm as a result of this incident.|
|ConMed/VCARE (Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator)||Model # 60-6085||While manipulating the uterus with the device, the balloon failed and this may have caused the device to come apart and the cervical cap to remain in the patient.|
|ConMed/VCARE (Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator)||Ref#60-6085-102 Lot # 0803111 Large||The tip of the balloon broke off and the end piece that is bell shaped remained attached and remained in the cervix. This was not noticed by the surgical team. Patient was seen in the surgeon's office 10 days following surgery and the piece of the device was discovered. The patient had been experiencing pain and malodorous odor. The surgeon admitted her to another hospital, other than where the surgery was performed, for prophylactic antibiotics. The patient is doing well at this time.|
|ConMed/VCARE (Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator)||Ref# 60-6085-100 Lot # 0801281 Standard||During a laparoscopic robotic assisted procedure, the VCARE broke down in parts into the patient's uterus. The physician scrubbed in, removed the uterus and all of the remaining parts of the VCARE (Uterine manipulator) through the vagina. No additional intervention was needed at the time.|
|ConMed/VCARE (Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator)||Serial # 606085101 Lot # 0801281 Small||VCare perforated uterus during robotic-assisted (using the daVinci system) laparoscopic-assisted vaginal hysterectomy with BSO (bilateral salpingo oopherectomy).|
|ConMed/VCARE (Vaginal-Cervical-Ahluwalia’s-Retractor-Elevator)||Ref # 60-6085-100 Lot # 0801281 Standard||Patient was scheduled to have a laparoscopic hysterectomy, appendectomy, and right salpingo oophorectomy. The physician initially placed the uterine manipulator via vagina (V Care Standard Size). When the laparoscopic procedure started, the surgery team discovered that the manipulator had perforated the uterus.|