VCARE 60-6085-200ARecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10653405003748), received between Jul 14, 2017 and Aug 14, 2026 — classified as 4 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Loose or Intermittent Connection

  A sales representative reported on behalf of a customer that the device, 60-6085-200A, SMALL,UTERINE MANIPULATOR,VAGINAL, was used in an unnamed procedure on(B)(6) 2026, and ¿the screw came loose. Instead of opening a new item the nurse held the unit in place for the remainder of the surgery. There was no delay our patient injury.¿. The procedure was completed. There was no report of medical/surgical intervention, or extended hospitalization for the patient. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260235 ↗
• MalfunctionAug 14, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252074 ↗
• MalfunctionJul 28, 2026Unstable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060125 ↗
• MalfunctionJul 28, 2026Unstable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059897 ↗
• MalfunctionJun 4, 2026Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-6085-200A SMALL,UTERINE MANIPULATOR,VAGINAL DEVICE WAS BEING USED ON (B)(6) 2026 DURING A HYSTERECTOMY PROCEDURE WHEN IT WAS REPORTED ¿V-CARE SIZE SMALL HANDLE FELL APART, AND ALL OF THE PIECES DETACHED. HAD TO REMOVE PIECES FROM PATIENT WITH SPONGE STICK.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND A ONE-HOUR DELAY WAS REPORTED. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS ¿STABLE¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392577 ↗
• MalfunctionApr 14, 2026Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF MEDWATCH REPORT: MW5184345, RECEIVED ON 20MAR2026. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 60-6085-200A, SMALL, UTERINE MANIPULATOR, VAGINAL. THIS WAS REPORTED AS A PRODUCT PROBLEM NOT AN ADVERSE EVENT. THE REPORT STATES THAT ON (B)(6) 2026, THE ¿INTERNAL/EXTERNAL CUP DETACHED FROM ITSELF. BALLOON DETACHED FROM VCARE¿. THE HEALTH EFFECT WAS REPORTED AS ¿NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS¿. A GOOD FAITH EFFORT WAS MADE TO OBTAIN FURTHER INFORMATION FROM THE REPORTER, BUT NO RESPONSE HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873598 ↗
• MalfunctionDec 19, 2025Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER MW5178967 ON (B)(6) 2025. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST A 60-6085-200A, SMALL, UTERINE MANIPULATOR, VAGINAL, DEVICE. THE DATE OF THE PROCEDURE WAS (B)(6) 2025. THE REPORT STATES, ¿UTERINE MANIPULATOR BROKE DURING SURGICAL PROCEDURE.¿ FURTHER ASSESSMENT WAS CONDUCTED AND THE REPORTED ADVISED ON (B)(6) 2025 THAT ¿THE HANDLE DISLODGED FROM THE OVER SHEATH WITH BALLOON COMPONENT.¿ THE DEVICE COMPONENTS THAT HAD FALLEN INTO THE PATIENT WERE REMOVED BY HAND. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT DUE TO THE INCIDENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DELAY. THE PATIENT STATUS IS REPORTED AS ¿DISCHARGED HOME¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848210 ↗
• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDSUN REPORT (B)(4) RECEIVED ON 30OCT25. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 60-6085-200A SMALL, UTERINE MANIPULATOR, VAGINAL. THE INCIDENT OCCURRED SOMETIME IN (B)(6) 2025 DURING A HYSTERECTOMY SALPINGO OOPHORECTOMY. THE REPORT STATES THAT THE ¿VCARE DEVICE CAME APART UPON REMOVAL OF UTERUS FROM PELVIS CAVITY. WE REASSEMBLED THE DEVICE ON THE BACK TABLE AFTER RETRIEVAL, MAKING SURE THAT ALL THE COMPONENTS WERE PRESENT. WE COMPARED IT TO A DIFFERENT PACKAGED VCARE TO MAKE SURE EVERYTHING WAS THERE.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554290 ↗
• MalfunctionOct 30, 2025Break; Detachment of Device or Device Component

  VCARE DEVICE CAME APART UPON REMOVAL OF UTERUS FROM PELVIS CAVITY. WE REASSEMBLED THE DEVICE ON THE BACK TABLE AFTER RETRIEVAL, MAKING SURE THAT ALL THE COMPONENTS WERE PRESENT. WE COMPARED IT TO A DIFFERENT PACKAGED VCARE TO MAKE SURE EVERYTHING WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425258 ↗
• InjuryOct 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-6085-200A, SMALL, UTERINE MANIPULATOR, VAGINAL DEVICE WAS USED IN A TLVH PROCEDURE ON (B)(6) 2025, AND ¿BALLOON WASN'T INFLATED AND UTERUS WAS PERFORATED¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND A DELAY OF 15 MINUTES. IT WAS FURTHER REPORTED THAT THERE WAS ¿NO HARM TO PATIENT", AND THE PATIENT¿S STATUS WAS "GOOD". THE CUSTOMER DID NOT RESPOND TO FURTHER QUESTIONS UPON REQUEST; THEREFORE, IT IS UNKNOWN WHETHER "BALLOON WASN'T INFLATED" INVOLVED A DEVICE MALFUNCTION, USER ERROR, OR OTHER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A PERFORATED UTERUS.

  Patient problems: Uterine Perforation

  MAUDE report 23254172 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE 60-6085-200A, SMALL, UTERINE MANIPULATOR, VAGINAL, DEVICE WAS BEING USED ON (B)(6) 2025 DURING A HYSTERECTOMY PROCEDURE WHEN IT WAS REPORTED ¿INFLATABLE BALLOON ON V-CARE FOUND TO BE DETACHED AFTER REMOVAL OF V-CARE INTRAOPERATIVELY. PAUSED SURGICAL PROCEDURE TO LOCATE MISSING PIECE. ALL COMPONENTS OF V-CARE WERE LOCATED BEFORE PROCEEDING. PRODUCT DISPOSED OF UPON COMPLETION OF SURGERY.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND 30-MINUTE DELAY WAS REPORTED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149028 ↗
• MalfunctionApr 8, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-6085-200A, SMALL, UTERINE MANIPULATOR, VAGINAL DEVICE WAS USED IN A ROBOTIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE, AND ¿CAME APART IN 3 PIECES (THAT WE KNOW OF) DURING PROCEDURE, PIECES HAD TO RETRIEVED FROM ABDOMINAL CAVITY.¿ FURTHER ASSESSMENT FOUND THE PROCEDURE WAS COMPLETED AS NORMAL, WITH A DELAY OF 3-5 MINUTES. ADDITIONAL COMMENTS FROM THE SURGEON INDICATED: "WHEN TRYING TO REMOVE THE UTERUS, THE MANIPULATOR CAME OFF. THAT HAPPENS ALL THE TIME SO NO BIG DEAL, BUT WHEN IT CAME OUT, IT WAS JUST THE HANDLE AND BLUE THING. THEN WE REACHED IN AND PULLED OUT THE GREEN CUP. AND ONCE WE GOT THE UTERUS OUT, WE SAW THE BALLOON PIECE IN THE PELVIS AND GRABBED IT OUT TOO. WE JUST SET IT ASIDE AND KEPT MOVING AND IT GOT TOSSED IN THE TRASH. I NEVER ACTUALLY LOOKED AT IT TO MAKE SURE IT WAS ALL TOGETHER. I ASSUMED MY STAFF DID, BUT I CANNOT BE SURE. WHEN I TOLD [STAFF] IT WAS BROKEN, SHE ASKED FOR THE PIECES AND IT WAS DUG OUT OF THE TRASH TO REPORT IT TO YOU.". THERE WAS NO INJURY AND NO REPORT OF MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21797492 ↗
• InjuryJul 24, 2024Material Separation; Material Separation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-6085-200A, VCARE 200A - SMALL DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON (B)(6) 2024, AND ¿THE BLUE CONE PORTION OF THE UTERINE MANIPULATOR FELL OFF DURING THE PROCEDURE. IT WAS DISCOVERED DURING THE REMOVAL OF THE INSTRUMENT. A VAGINAL TEAR WAS DISCOVERED AND SUTURED BY THE SURGEON.¿. THE PROCEDURE WAS COMPLETED WITH A ONE-HOUR DELAY AND WITHOUT THE USE OF AN ALTERNATE DEVICE. THE PATIENT'S STATUS WAS REPORTED AS "DISCHARGED". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A VAGINAL TEAR SUTURED BY THE SURGEON.

  Patient problems: Laceration(s)

  MAUDE report 19817968 ↗
• InjuryJul 3, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 60-6085-200A, VCARE 200A SMALL WAS BEING USED ON (B)(6) 2024 DURING A HYSTERECTOMY PROCEDURE WHEN IT WAS REPORTED ¿VCARE CAME APART INSIDE PATIENT.¿. FURTHER ASSESSMENT WAS ATTEMPTED BUT WE HAVE RECEIVED NO RESPONSE TO DATE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE POSSIBILITY OF A FOREIGN BODY LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19665775 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5153637) RECEIVED ON 23APR24. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 60-6085-200A VCARE 200A - SMALL. THE REPORT STATES THAT ¿THE BALLOON FROM THE VCARE UTERINE MANIPULATOR FELL OFF INSIDE PATIENT ABDOMEN. THE BALLOON FELL OF THE MANIPULATOR AND INTO ABDOMEN. IT WAS RETRIEVED BY SURGEON AND ACCOUNTED FOR...¿. THERE WAS NO REPORT OF INJURY OR IMPACT TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297038 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5153636) RECEIVED ON 23APR24. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 60-6085-200A VCARE 200A - SMALL. THE REPORT STATES THAT ON 25MAR24 ¿THE BALLOON FROM THE VCARE UTERINE MANIPULATOR FELL OFF INSIDE PATIENT ABDOMEN. THE BALLOON FELL OF THE MANIPULATOR AND INTO ABDOMEN. IT WAS RETRIEVED BY SURGEON AND ACCOUNTED FOR...¿. THERE WAS NO REPORT OF INJURY OR IMPACT TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297036 ↗
• MalfunctionApr 25, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE 60-6085-200A, VCARE 200A - SMALL, DEVICE WAS BEING USED DURING A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED ¿DR. HAS HAD ANOTHER OCCURRENCE OF THE BALLOON BREAKING OFF OF THE VCARE MANIPULATOR. WE HAVE STOPPED USING THEM FOR HER CASES AT THIS TIME UNTIL WE CAN GET SOME DEFINITIVE ANSWERS TO WHAT¿S HAPPENING. NO PATIENT HAS BEEN HARMED AS THE BALLOON HAS BEEN RETRIEVED EVERY TIME.¿ THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180585 ↗
• MalfunctionApr 11, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 60-6085-200A, VCARE 200A ¿ SMALL WAS BEING USED DURING A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2024 DATE WHEN IT WAS REPORTED ¿THE TIP OF VCARE MANIPULATOR BROKE OFF DURING REMOVAL OF THE ITEM AFTER THE COLPOTOMY WAS COMPLETED. THE SURGEON REMOVED THE PIECE WITHOUT ANY ISSUE. NO HARM OCCURRED TO THE PATIENT AND THERE WAS NO DELAY.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND NO DELAY WAS REPORTED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086143 ↗
• MalfunctionFeb 14, 2024Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT MW5149855 ON (B)(6)2024. THE REPORT WAS FOUND TO BE WRITTEN AGAINST 60-6085-200A, VCARE 200A - SMALL, THAT WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023. THE REPORT STATED, ¿AT THE TIME OF REMOVING THE UTERUS THROUGH THE VAGINA, THE TOP OF THE V-CARE BROKE OFF WITH THE CUP AND BALLOON PORTION IN ONE PIECE AND THE HANDLE THE OTHER. THE CUP AND BALLOON WERE PLACED INTO THE VAGINA AND WERE REMOVED IN THEIR ENTIRETY THE ENTIRE DEVICE WAS GIVEN TO THE NURSE IN THE ROOM. THERE WAS NO HARM TO THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701648 ↗
• MalfunctionJan 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE 60-6085-200A, VCARE 200A - SMALL WAS REPORTED AS ¿DR. HAS REPORTED MULTIPLE ISSUES WHERE THE BALLOON ON THE END OF THE VCARE UTERINE MANIPULATOR IS BREAKING OFF INSIDE THE PATIENT. THUS FAR, A PATIENT HAS NOT BEEN HARMED AND THE BALLOONS HAVE BEEN RETRIEVED BUT WE WOULD LIKE TO REPORT THE MOST RECENT LOT# THAT BROKE FOR INVESTIGATION.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597285 ↗
• MalfunctionJan 2, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE 60-6085-200A, VCARE 200A - SMALL DEVICE WAS BEING USED IN A TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6)2023 WHEN THE "CUFF AND BALLON BROKE OFF IN THE PATIENTS". FURTHER ASSESSMENT FOUND THAT THE DEVICE HAD FRAGMENTED, FRAGMENTS FELL INTO THE SURGICAL SITE AND WERE REMOVED WITH LAPAROSCOPIC INSTRUMENTS. THE SURGERY WAS COMPLETED AS NORMAL WITHOUT THE USE OF AN ALTERNATE DEVICE, AND WITH A DELAY OF UNKNOWN DURATION. THERE WAS NO REPORTED IMPACT OR INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITAL STAY FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428674 ↗
• MalfunctionSep 5, 2023Unintended Movement; Unintended Movement

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-6085-200A, VCARE 200A ¿ SMALL WAS BEING USED ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE AND ¿IT WAS REPORTED THAT THERE WAS A SNAPPING SOUND IN THE HANDLE PART WHEN LIFTING. WHEN THE DISTRIBUTOR INSPECTED IT, IT WAS CONFIRMED THAT THE HANDLE PART WAS IN A STATE OF SPINNING.¿ THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681672 ↗
• MalfunctionAug 16, 2023Unintended Movement; Unintended Movement

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDSUN REPORT (4401610000-2023-8006) RECEIVED ON 28JUL23. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 60-6085-200A VCARE 200A - SMALL. THIS WAS REPORTED AS A PRODUCT PROBLEM NOT AN ADVERSE EVENT. THE REPORT STATES THAT ON 3JUL23 DURING A LAPAROSCOPIC HYSTERECTOMY ¿A SMALL VCARE PLUS WAS OPENED. WHEN ATTEMPTING TO MANIPULATE AND MOVE UTERUS THE HANDLE WAS NOTED TO BE SPINNING AROUND. THE MANIPULATOR WAS NOT ABLE TO BE USED BECAUSE THE HANDLE WAS NOT SECURE. THE VCARE PLUS WAS REMOVED FROM THE SURGICAL FIELD AND ANOTHER VCARE PLUS WAS OBTAINED. THE PROCEDURE WAS COMPLETED. NO UNTOWARD PATIENT AFFECT.¿ THERE WAS INJURY OR IMPACT TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557003 ↗
• MalfunctionJun 6, 2023Unintended Movement; Unintended Movement

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-6085-200A, VCARE 200A ¿ SMALL WAS BEING USED ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE AND ¿THE HANDLE PART TURNS ROUND AND ROUND.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. CONMED JAPAN HAS REPORTED THIS EVENT AND A MEDWATCH REPORT WILL BE FILED IN CONJUNCTION WITH ALL OUS ADVERSE EVENTS. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17072955 ↗
• MalfunctionApr 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-6085-200A, VCARE 200A - SMALL WAS BEING USED ON (B)(6) 2023 DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE AND ¿THE VCARE THAT WAS BEING USED, THE PROXIMAL OCCLUDER PORTION HAD SNAPPED OFF OR AT LEAST WAS NOT LONGER ATTACHED TO THE SHAFT OF THE VCARE WHEN THE UTERUS WAS REMOVED. THERE WERE NO ISSUES WITH THE REMOVAL OF THE UTERUS FROM THE PATIENT BUT THAT PORTION WAS NO LONGER ATTACHED.¿. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH NO DELAY AND NO ALTERNATE DEVICE WAS USED. AFTER FURTHER ASSESSMENT IT WAS FOUND ¿WE COULD NOT TELL IF THE BLUE VAGINAL CUP SIMPLY FELL OFF OR SLID OFF THE END. EVERYTHING WAS VERY EASILY RETRIEVED FROM THE SURGICAL SITE, NO ISSUES THERE.¿ THERE WAS NO SUBSTANTIAL FORCE USED WHEN REMOVING THE VCARE. IT WAS NOTED, "THE UTERUS WAS QUITE SMALL. THERE WAS NO COMPLAINT FROM THE STAFF WHILE USING THE DEVICE, IT HAD BEEN A VERY TOUGH CASE FROM THE SURGEONS STANDPOINT." THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762337 ↗