FDA Adverse Event Summary report: N

CONMED VCARE STANDARD CERVICAL CUP

MDR report key: 2286116 · Received September 30, 2011

Report

Report Number
2286116
Date Received
September 30, 2011
Date of Event
September 15, 2011
Report Date
September 30, 2011
Manufacturer
CONMED CORPORATION
Product Code
LKF
Report Source
User Facility report
Reporter Location
IL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

CERTIFIED SURGICAL TECH AND NURSES COMPLAIN OF WRIST PAIN/INJURY DUE TO V-CARE DEVICE. ONE SURGICAL TECH DEVELOPED A WRIST INJURY RELATED TO THE USE OF A UTERINE MANIPULATOR DUING ROBOTIC GYN PROCEDURES. SHE REPORTED THUMB, HAND, AND WRIST PAIN. SURGICAL TECH REPORTS DIFFICULTY HOLDING AND MANIPULATING THE INSTRUMENT PARTICULARLY FOR SUSTAINED PERIORDS OF TIME. SHE REPORTS THAT WITH A LIMITED NUMBER OF STAFF TRAINED IN THIS EQUIPMENT SHE MAY PERFORM THIS TASK FOR SEVERAL PORCEDURES IN A ROW AND THAT PROCEDURE TIMES CAN VARY FROM 45 MINTUES TO SEVERAL HOURS. THIS ISSUE OF REPETITIVE WORK INJURY TO WRISTS AND ARMS OCCURS IN ALL GYN PROCEDURES WHILE MANIPULATING THE UTERUS FOR EXTEDNED PERIOD OF TIME. THE ROBOTICS PIECE IS EVEN WORSE AS THE PROCEDURES ARE AN EXTENDED LENGTH OF TIME FAR EXCEEDING THE TYPICAL LAPARSCOPIC GYN PROCEDURE. BUT FOR BOTH CASES THE UTERINE MANIPULATOR MUST BE HELD FOR 1 HOUR OR MORE AND THE HANDPIECE ON THE INSTRUMENT IS TOO NARROW. IT CASUES STRAIN AND MANY STAFF MUST BE TREATED, I.E. HAND BRACES AT THE END OF THE DAY AND ONE EMPLOYEE ON A LEAVE OF ABSENCE FOR AN EXTENDED PERIOD. AN ERGONOMICS ASSESSMENT OF THE JOB TASK OF USING A UTERINE MANIPULATOR WHILE ASSISTING IN GYN SURGERY WAS COMPLETED BY OUR REHAB PHYSICAL THERAPIST. HER RESULTS: THE V-CARE UTERINE MANIPULATOR IS S SHAPED WITH A SMALL PLASTIC HANDLE WITH 3 FINGER INDENTATIONS. WHEN THIS IS USED WITH THE ROBOT, THE PATIENT'S LEGS ARE APPROXIMATED TO POSITION THE ROBOT AND RESULT IN LESS SPACE FOR THE ASSISTING NURSE/TECH TO STAND. THE LIMITED WORK SPACE REQUIRES THE STAFF MEMBER TO USE A LONGER FORWARD OR LATERAL REACH WHILE TRYING TO GRASP, MAINTAIN PRESSURE AND MANIPULATE THE INSTRUMENT. CONCERNS: STATIC POSTURES OF THE HAND, SHOULDER AND BACK GREATER THAN 1 HOUR DURATION. RADIAL GRASP REQUIRED W/V-CARE DUE TO HANDLE SHAPE AND SIZE, INCREASED RADIAL DEVIATION TO MANIPULATE, LIMITED ABILTY TO ADJUST ARM POSITION DUE TO MAINTANENCE OF STERILE FIELD, POSITIONING OF THE MONITOR AND LIMITED SPACE.======================MANUFACTURER RESPONSE FOR CONMED V-CARE UTERINE MANIPULATOR, CONMED V-CARE (PER SITE REPORTER).======================STAFF STATED THAT THEY REPEATEDLY INSTRUCTED THE REP ABOUT THEIR CONCERNS REGARDING THE V-CARE MANIPULATOR AND THEY STATED THAT THEY WERE PLANNING TO MAKE CHANGES; BUT NOTHING HAS BEEN CHANGED.======================MANUFACTURER RESPONSE FOR CONMED V-CARE UTERINE MANIPULATOR, CONMED V-CARE (PER SITE REPORTER).======================REPS WERE INSTRUCTED OF STAFF CONCERNS/INJURIES RELATED TO V-CARE HANDLE AND STATED CHANGES WERE GOING TO TAKE PLACE, BUT NO CHANGES HAVE OCCURRED.======================MANUFACTURER RESPONSE FOR CONMED V-CARE UTERINE MANIPULATOR, CONMED V-CARE (PER SITE REPORTER).======================STAFF HAVE INSTRUCTED REPS OF THE PROBLEM CONCERNING THE HANDLE RE: WRIST INJURIES. REP STATED THAT CHANGES WERE PLANNED, BUT NO CHANGES HAVE OCCURRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CONMED VCARE STANDARD CERVICAL CUP CONMED V-CARE UTERINE MANIPULATOR LKF CONMED CORPORATION 60-6085-100 *
2 CONMED VCARE SMALL CERVICAL CUP CONMED V-CARE UTERINE MANIPULATOR LKF CONMED CORPORATION 60-6085-101 *
3 CONMED VCARE LARGE CERVICAL CUP CONMED V-CARE UTERINE MANIPULATOR LKF CONMED CORPORATION 60-6085-102 *

Patients

Seq Age Sex Outcome Treatment
1 *