VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR
Report
- Report Number
- 1320894-2011-00081
- Event Type
- Injury
- Date Received
- November 7, 2011
- Date of Event
- September 15, 2011
- Report Date
- November 28, 2011
- Manufacturer
- CONMED CORPORATION
- Product Code
- LKF
- PMA / PMN Number
- K071907
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THE DEVICE IN QUESTION, VCARE, IS A DISPOSABLE, SINGLE-USE DEVICE FOR MANIPULATION OF THE UTERUS AND CERVIX IN SURGICAL AND DIAGNOSTIC PROCEDURES. THE DEVICE CONSISTS OF A MANIPULATOR TUBE HAVING AN INFLATABLE BALLOON AT ITS PROXIMAL END AND AN ANATOMICALLY CONFIGURED CANNULA / HANDLE FOR MAINTAINING PROPER ATTITUDE OF THE UTERUS AT THE DISTAL END. THE VCARE INCORPORATES A SYSTEM OF CUP-LIKE ELEVATORS TO PROVIDE MANIPULATION OF THE UTERUS, AND RETRACTION AND ELEVATION OF THE CERVIX. THE CONMED VCARE IS INDICATED FOR MANIPULATION OF THE UTERUS AND INJECTION OF FLUIDS OR GASES DURING LAPAROSCOPIC PROCEDURES SUCH AS LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (LAVH), TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), MINILAP, LAPAROSCOPIC TUBAL OCCLUSION, OR DIAGNOSTIC LAPAROSCOPY AND ALSO MAINTAINS PNEUMOPERITONEUM BY SEALING THE VAGINA ONCE A COLPOTOMY IS PERFORMED. DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW WAS NOT ACCOMPLISHED FOR THE LOT NUMBER OF THE DEVICE WAS NOT AVAILABLE. A TWENTY-FOUR (24) MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR THE VCARE PRODUCT FAMILY SHOWED ONLY ONE (1) ADDITIONAL COMPLAINT WHERE THE END-USER "HAD HAND CRAMPS AND STRUGGLED TO HOLD THE DEVICE DURING THIS LENGTHY CASE". THE OCCURRENCE OF THIS TYPE OF COMPLAINT IS EXTREMELY LOW. THE CPM, COMPLAINTS PER MILLION UNITS SOLD, FOR VCARE ERGONOMIC HANDLE ISSUES FOR THIS TIME PERIOD OF TWENTY-FOUR (24) MONTHS IS: (2 COMPLAINTS / 264,831 UNITS SOLD) X 1 MILLION = 7.5 CPM. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION OF THE DEVICE COULD NOT BE ASSESSED (I.E., ANY DEVICE DAMAGE, MALFUNCTION OR DEFECTS). THE CAUSE OF THIS COMPLAINT IS BELIEVED TO BE USE RELATED DUE TO LIMITED TRAINED STAFF, LIMITED WORKING SPACE FOR STAFF, AND LENGTHY PROCEDURES. KEY CONTRIBUTING FACTORS IDENTIFIED BY THE END-USER FACILITY INCLUDE: A SURGICAL TECHNICIAN MAY PERFORM SEVERAL PROCEDURES IN A ROW VARYING FROM 45 MINUTES TO SEVERAL HOURS, DUE TO A LIMITED NUMBER OF TRAINED STAFF, LIMITED WORKSPACE USING THE ROBOT MACHINERY REQUIRES STAFF TO USE A LONGER FORWARD OR LATERAL REACH WHILE TRYING TO GRASP, MAINTAIN PRESSURE AND MANIPULATE THE INSTRUMENT, AND, ROBOTIC PROCEDURES TAKE AN EXTENDED LENGTH OF TIME, FAR EXCEEDING THE TYPICAL LAPAROSCOPIC GYN PROCEDURE. REVIEW OF THE DFMEA, DESIGN FAILURE MODES AND EFFECTS ANALYSIS, DOCUMENT FOR VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATORS STATES THAT THE, "HANDLE MUST BE ERGONOMIC AND COMFORTABLE FOR UP TO 4 HOUR USE. POTENTIAL FAILURE COULD RESULT IN INCONVENIENCE AND PHYSICIAN DISCOMFORT". THIS IS ANALYZED AS A SEVERITY OF 4 (MINOR - ITEM DOES NOT CONFORM. DEFECT NOTICED BY MOST CUSTOMERS. USER WILL EXPERIENCE MINOR NEGATIVE IMPACT ON THE PRODUCT.), AN OCCURRENCE RATE OF 1 (EXTREMELY UNLIKELY), AND A DETECTABILITY RATE OF 1 (ALMOST CERTAIN). THIS COMBINATION RESULTS IN AN ACTION PRIORITY LEVEL OF A, WHERE CORRECTIVE ACTIONS ARE OPTIONAL OR NOT REQUIRED. REVIEW OF HAZARD AND RISK ANALYSIS FOR VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATORS REVEALS THAT WHEN CONSIDERING LONG-TERM USE EFFECTS, ERGONOMIC EFFECTS, THE DESIGN OF THE HANDLE WAS CONSIDERED. WHEN THE VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR WAS DESIGNED ROBOTIC SURGERY WAS NOT AS PREVALENT AS IT IS TODAY. WITH THE GYNECOLOGICAL SURGICAL PATIENT IN NORMAL LITHOTOMY POSITION, THERE AFFORDS AMPLE ROOM FOR THE SURGICAL ASSISTANT AT THE CAUDAL END OF THE PATIENT TO COMFORTABLY MANIPULATE THE UTERINE MANIPULATOR SUCH AS THE VCARE DEVICE. NORMAL LITHOTOMY POSITIONING OF THE PATIENT ALLOWS THE SURGICAL ASSISTANT TO SWITCH HANDS AS NEEDED FOR LONG-TERM SURGICAL SITUATIONS WITHOUT COMPROMISING THE STERILE SURGICAL FIELD. WITH ROBOTIC SURGERY, THE PATIENT'S LEGS ARE POSITIONED WITH THEIR KNEES MUCH CLOSER TOGETHER TO CREATE THE SPACE NEEDED TO ACCOMMODATE THE ROBOTIC MODULES ON EITHER THE RIGHT OR LEFT LATERAL SIDE OF THE PATIENT. THIS ALTERED LITHOTOMY PATIENT POSITIONING DECREASES THE REMAINING SPACE NEEDED TO SITUATE THE SURGICAL ASSISTANT FOR MANIPULATION AND POSTURING OF THE UTERUS DURING THE ROBOTIC-ASSISTED LAPAROSCOPIC SURGICAL PROCEDURE. THE END-USER REPORTING THE ASSOCIATED MEDWATCH DESCRIBED THIS POSITIONING PROBLEM AS FOLLOWS, "WITH THE ROBOT, THE PATIENT'S LEGS ARE APPROXIMATED TO POSITION THE ROBOT AND RESULTS 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." BESIDES HOLDING THE UTERINE MANIPULATOR AT A FULLY EXTENDED ARMS LENGTH, THE LIMITED SPACE CONSTRAINTS IN ROBOTIC PROCEDURES MAKE IT DIFFICULT FOR A SIMPLE CHANGE OF HANDS WITHOUT THE POSSIBILITY OF CONTAMINATING THE STERILE SURGICAL FIELD. THIS CHANGE OF HANDS IS BENEFICIAL TO MAINTAIN THE COMFORT OF THE SURGICAL ASSISTANT IN ANY LENGTHY GYNECOLOGICAL PROCEDURE. THIS CHANGE IN PATIENT POSITIONING NEEDED TO ACCOMMODATE THE ROBOTIC MODULES HAS RESULTED IN A MUCH DECREASED AREA TO PLACE A SURGICAL ASSISTANT RESULTING IN THE POSSIBILITY OF COMPROMISING YOUR STERILE SURGICAL FIELD WITH MINIMAL STAFF MOVEMENT. WHEN CONSIDERING THE MORE LENGTHY GYNECOLOGICAL SURGICAL PROCEDURES, THIS DECREASED AREA HAS RESULTED IN ERGONOMIC ISSUES FOR THE SURGICAL ASSISTANT, WHETHER HANDLING A VCARE DEVICE, OR, ANY OTHER TYPE OR BRAND OF UTERINE MANIPULATOR. THIS SPACE CONSTRAINT ISSUE HAS BEEN ADDRESSED BY SOME FACILITIES PERFORMING ROBOTIC PROCEDURES. THESE FACILITIES HAVE INCLUDED A ROBOTIC ARM TO HOLD OR MANIPULATE THE UTERINE DEVICE DUE TO THESE SPATIAL CONSTRAINTS. A WARNING CONCERNING THIS IS ADDRESSED IN THE VCARE DFU, DIRECTIONS FOR USE, WHICH STATES, "IF BENDING VCARE IS NECESSARY FOR USE WITH ROBOTIC INSTRUMENTS, THEN ALL DEVICE SYSTEMS MUST BE TESTED BEFORE USE TO ENSURE FUNCTIONALITY". THIS ELIMINATES THE ERGONOMIC ISSUE THAT IS DESCRIBED ABOVE. CONMED IS CONSIDERING THIS REPORT CLOSED.
THE DEVICE IN QUESTION IS NOT BEING RETURNED TO CONMED FOR EVALUATION. WHEN A QUALITY ENGINEERING EVALUATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED, "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 DURING ROBOTIC GYN PROCEDURES. SHE REPORTED THUMB, HAND, AND WRIST PAIN. SURGICAL TECH REPORTS DIFFICULTY HOLDING AND MANIPULATING THE INSTRUMENT PARTICULARLY FOR SUSTAINED PERIODS OF TIME. SHE REPORTS THAT WITH A LIMITED NUMBER OF STAFF TRAINED IN THIS EQUIPMENT SHE MAY PERFORM THIS TASK FOR SEVERAL PROCEDURES IN A ROW AND THAT PROCEDURE TIMES CAN VARY FROM 45 MINUTES TO SEVERAL HOURS. THIS ISSUE OF REPETITIVE WORK INJURY TO WRISTS AND ARMS OCCURS IN ALL GYN PROCEDURES WHILE MANIPULATING THE UTERUS FOR EXTENDED PERIODS OF TIME. THE ROBOTICS PIECE IS EVEN WORSE AS THE PROCEDURES ARE AN EXTENDED LENGTH OF TIME FAR EXCEEDING THE TYPICAL LAPAROSCOPIC GYN PROCEDURE. FOR BOTH CASES THE UTERINE MANIPULATOR MUST BE HELD FOR 1 HOUR OR MORE AND THE HANDPIECE ON THE INSTRUMENT IS TOO NARROW. IT CAUSES 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 WITH V-CARE DUE TO HANDLE SHAPE AND SIZE, INCREASED RADIAL DEVIATION TO MANIPULATE, LIMITED ABILITY TO ADJUST ARM POSITION DUE TO MAINTENANCE OF STERILE FIELD, POSITIONING OF THE MONITOR AND LIMITED SPACE. 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."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR | VCARE UTERINE MANIPULATOR, STANDARD SIZE | LKF | CONMED CORPORATION | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |