VCARE 60-6085-202ARecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10653405003809), received between Sep 4, 2018 and Jun 11, 2026 — classified as 3 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Material Separation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DEVICE, 60-6085-202A, LG, UTERINE MANIPULATOR, WAS USED IN A SURGICAL PROCEDURE ON (B)(6) 2026, AND ¿A DISPOSABLE UTERINE MANIPULATOR MALFUNCTIONED. WHILE THE DEVICE WAS IN THE CERVICAL CANAL, IT APPEARED TO BREAK APART INTO 3 PIECES. THE GREEN CUFF AND BALLOON HAD TO BE RETRIEVED FROM INSIDE THE PATIENT. THERE WAS NO HARM TO 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 25472431 ↗
• MalfunctionJun 10, 2026Material Separation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DEVICE, 60-6085-202A, LG,UTERINE MANIPULATOR, 120V, WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 26, AND ¿DURING PROCEDURE, ITEM BROKE INSIDES PATIENTS VAGINAL CANAL, NO INJURIES AND REMOVED FROM USE. USED ANOTHER MANIPULATOR.¿. THERE WAS NO REPORT OF INJURY, 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 25459178 ↗
• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-6085-202A, LG, UTERINE MANIPULATOR DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2025, AND ¿THE BALLON TIP & GREEN PLASTIC PART FELL OFF INSIDE OF THE PATIENT. HAD TO RETRIEVE THE PARTS THAT FELL OFF FROM INSIDE THE PATIENT.¿ THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND A DELAY OF 15-30 MINUTES. FURTHER ASSESSMENT CONFIRMED "THAT ALL PIECES WERE ACCOUNTED FOR BEFORE PATIENT LEFT OR.". THERE WAS NO REPORT OF INJURY, 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 23346303 ↗
• MalfunctionJul 17, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE THAT THE 60-6085-202A, LG, UTERINE MANIPULATOR DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿V CARE THAT WAS USED TODAY THAT BROKE OFF INSIDE THE PATIENT ONCE THE UTERUS HAD BEEN DISCONNECT FROM ALL TISSUE. THE BALLOON BROKE OFF INSIDE THE ABDOMEN AND THE BLUE AND GREEN PARTS SNAPPED OFF INSIDE THE VAGINA. LUCKILY THIS WAS NOTICED, AND ALL BROKEN PARTS WERE RETRIEVED.¿. 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 22529340 ↗
• MalfunctionJul 17, 2025Material Separation; Material Separation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-6085-202A, LG,UTERINE MANIPULATOR DEVICE WAS BEING USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿I WAS CONTACTED BY HOSPITAL STAFF TO REPORT THE DISASSEMBLY OF THE VCARE DURING THE PROCEDURE. IT WAS CONFIRMED THAT ALL PARTS WERE RETRIEVED. THERE WAS LIMITED TIME DELAY AND NORMAL OPERATIVE PROCEDURE WAS FOLLOWED TO COMPLETE CASE.¿ THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE AND A 5-MINUTE DELAY. THERE WAS NO REPORT PF INJURY, MEDICAL OR SURGICAL 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 22529337 ↗
• MalfunctionMay 29, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-6085-202A, LG,UTERINE MANIPULATOR, WAS BEING USED DURING A HYSTERECTOMY PROCEDURE ON 9MAY25 WHEN IT WAS REPORTED, ¿CUSTOMER STATED THE DISTAL END (COLPOTOMY CUP) AND BLUE CUP BROKE OFF OF THE HANDLE AND WERE LEFT IN THE PATIENT. THEY USED A GRASPER TO PULL THEM OUT. NO HARM OCCURRED TO THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED. THE REPORTER STATES THAT THE PATIENT IS ¿FINE¿. 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 22103833 ↗
• MalfunctionMar 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-6085-202A, LG, UTERINE MANIPULATOR DEVICE WAS USED IN UNNAMED SURGICAL PROCEDURE ON (B)(6) 2025, AND ¿ITEM BROKE DURING SERVICE; USED ANOTHER DEVICE; NO ISSUES WITH OUTCOME OF PROCEDURE¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF ¿ANOTHER DEVICE¿ AND A DELAY OF ONE TO FIVE MINUTES. PER ASSESSMENT, THE DETAILS OF THE TYPE OF DEVICE BREAKAGE ARE UNKNOWN; HOWEVER, IT WAS CONFIRMED THAT NO FRAGMENT OR COMPONENT FELL INTO THE PATIENT. THE OR MANAGER STATED, "POSSIBLE USER-ERROR", AND THAT THE "PATIENT WAS NOT HARMED DURING THIS INCIDENT". THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT/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 21572148 ↗
• MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-6085-202A, LG,UTERINE MANIPULATOR WAS BEING USED ON (B)(6) 2024 AND ¿WE WERE DOING A ROBOTIC HYSTERECTOMY TODAY. AFTER THE UTERUS WAS ALL DISSECTED, THE SURGEON PULLED ON THE VCARE HANDLE AND THE ¿CUP¿ BROKE OF INSIDE THE PATIENT. THERE WAS 4 PIECES THAT WE RETRIEVED. HAD TO FISH PARTS OF VCARE AND CONFIRM ALL PARTS WERE FOUND.¿. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THERE WAS A 20 MINUTE DELAY. 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 20368381 ↗
• MalfunctionAug 2, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 60-6085-202A, VCARE 200A ¿ LARGE WAS BEING USED ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿DEVICE BROKE/FELL APART INTO MULTIPLE PIECES. ALL PIECES WERE IDENTIFIED AND REMOVED SAFELY FROM THE PATIENT. NO INJURIES OCCURRED¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. 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 19891437 ↗
• MalfunctionAug 2, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE 60-6085-202A, VCARE 200A - LARGE, DEVICE WAS BEING USED ON (B)(6) 2024 DURING A ROBOTIC ASSISTED TOTAL HYSTERECTOMY PROCEDURE WHEN IT WAS REPORTED ¿V -CARE BROKE INSIDE THE PATIENT WHEN SURGEON WAS RETRIEVING SPECIMEN.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND ALL FRAGMENTS WERE RETRIEVED. 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 19891185 ↗
• MalfunctionMay 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-6085-202A, VCARE 200A - LARGE, WAS BEING USED IN A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿BROKE OFF INSIDE OF PATIENT BALLOON ALSO FELL OUT. THEY DID RETRIEVE IT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR 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 19219805 ↗
• MalfunctionApr 23, 2024Material Fragmentation; Material Fragmentation

  A CUSTOMER REPORTED THAT THE 60-6085-202A, VCARE 200A ¿ LARGE DEVICE WAS BEING USED DURING A ROBOTIC HYSTERECTOMY PROCEDURE ON 05APR24, AND ¿BROKE OFF INSIDE OF PATIENT ALL PARTS ACCOUNTED FOR¿. THERE WAS NO REPORT OF INJURY, 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 19166814 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-6085-202A, VCARE 200A - LARGE, WAS BEING USED IN A ROBOTIC HYSTERECTOMY PROCEDURE ON 5APR24 WHEN IT WAS REPORTED, ¿THE PRODUCT BROKE WHILE INSIDE THE VAG, ALL PARTS WHERE ACCOUNTED FOR AND RETRIEVED.¿. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT ANY DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR 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 19162419 ↗
• MalfunctionFeb 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-6085-202A, VCARE 200A - LARGE, WAS BEING USED DURING A HYSTERECTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿V-CARE LARGE BROKE OFF DURING MANIPULATION IN PATIENT. BOTH ITEMS HAD MULTIPLE FAILURES AND MULTIPLE PIECES HAD TO BE RETRIEVED.¿. A SECOND SAME DEVICE WAS USED AS AN ALTERNATE AND HAD THE SAME FAILURE. FOLLOW UP ASSESSMENT FOUND THAT COMPONENTS FROM BOTH DEVICES WERE RETRIEVED FROM THE PATIENT BY UNKNOWN MEANS. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR 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 18666609 ↗
• MalfunctionNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE 60-6085-202A, VCARE 200A ¿ LARGE WAS BEING USED DURING A HYSTERECTOMY TOTAL VAGINAL ROBOT ASSISTED PROCEDURE ON (B)(6) 2023 AND THE ¿THE WHITE HANDLE CAME OFF THE DEVICE. THERE WERE NO INJURIES TO PATIENT OR STAFF.¿. PER FURTHER ASSESSMENT IT WAS FOUND, THE DEVICE WAS IN THE UTERUS AT THE TIME THE HANDLE CAME OFF AND ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ¿ANOTHER DEVICE¿ AND THERE WAS NO DELAY. THERE WAS NO 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 18147284 ↗
• MalfunctionNov 14, 2023Unintended Movement; Unintended Movement

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DEVICE, 60-6085-202A, VCARE 200A ¿ LARGE, WAS BEING USED DURING A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2023 WHEN THE ¿V-CARE HANDLE BROKE DURING PROCEDURE¿. FOLLOW-UP ASSESSMENT REVEALED THAT THE HANDLE BROKE AS SOON AS IT WAS INSERTED; THE UTERUS WAS BEING REMOVED VAGINALLY WITH THE VCARE DEVICE WHEN THE HANDLE STARTED SPINNING FREELY; THE CORRECT AMOUNT OF PRESSURE WAS USED IN ORDER TO GAIN VISIBILITY DURING THE CASE; THERE WAS NO FRAGMENTATION OF THE DEVICE.THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO 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 18130398 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF HIS CUSTOMER THAT THE 60-6085-202A, VCARE 200A ¿ LARGE WAS BEING USED IN AN UNNAMED SURGICAL PROCEDURE ON (B)(6) 2023, ¿AND WHEN THE SURGEON WENT TO INSTILL THE BALLOON, IT BROKE COMPLETELY OFF¿. A GOOD FAITH EFFORT TO OBTAIN FURTHER INFORMATION ABOUT THE PROCEDURE OR PATIENT WAS UNSUCCESSFUL. 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 17951182 ↗
• MalfunctionOct 11, 2023Failure to Deflate; Failure to Deflate

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-6085-202A, VCARE 200A ¿ LARGE WAS TO BE USED IN A HYSTERECTOMY PROCEDURE ON (B)(6) 2023 AND, DURING PRE-OPERATIVE TESTING, THEY FOUND THE ¿VCARE BALLOON NOT DEFLATING¿. 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 17913371 ↗
• InjurySep 26, 2023Break; Break

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT MW5144558 ON 08SEP23. THE REPORT WAS FOUND TO BE WRITTEN AGAINST 60-6085-202A, VCARE 200A - LARGE, THAT WAS BEING USED DURING A TAH BSO LAPAROSCOPIC, CYSTOSCOPY PROCEDURE ON 20JUL23. THE REPORT STATED, ¿RESIDENT HAD V-CARE IN VAGINAL TO MANIPULATE THE UTERUS DURING SURGERY. WHEN SHE LIFTED THE UTERUS FOR BETTER VISUALIZATION, THE INSTRUMENT SNAPPED.¿. NO FURTHER INFORMATION WAS INDICATED BY THE PROVIDER FOR ADDITIONAL INFORMATION. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿DISCHARGED TO HOME STABLE¿. THIS REPORT IS BEING RAISED ON REPORTED INJURY DUE TO THE POSSIBILITY OF THE PATIENT RETAINING A FOREIGN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817623 ↗
• MalfunctionSep 13, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-6085-202A, VCARE 200A - LARGE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED "PRODUCT SNAPPED IN HALF WHILE IN USE.¿ THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE POSSIBILITY OF FOREIGN BODY LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739152 ↗
• MalfunctionAug 24, 2023Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE 60-6085-202A, VCARE 200A ¿ LARGE WAS BEING USED DURING A HYSTERECTOMY PROCEDURE ON (B)(6) 2023 AND THAT, ¿AFTER TALKING TO DR. MORE ABOUT WHAT HAPPENED, HE INFORMED ME THAT THE V-CARE FELL APART WHILE IN THE PATIENT.¿ FURTHER ASSESSMENT INDICATED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED AS NORMAL. 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 17612397 ↗
• InjuryAug 2, 2023Detachment 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 17JUL23. 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 60-6085-202A, VCARE 200A ¿ LARGE. THE REPORT STATES THAT ON 6APR21 THERE WAS A ¿RETAINED FOREIGN BODY. THE PATIENT REPRESENTED TO THE OFFICE AFTER HAVING A CT THAT DEMONSTRATED RETAINED CUP OF VAGINAL MANIPULATOR THAT WAS USED AT THE TIME OF HER SUPRACERVICAL HYSTERECTOMY AND UNDERWENT EXAM UNDER ANESTHESIA AND REMOVAL OF FOREIGN OBJECT THIS MORNING. IT'S APPARENT THAT THE UTERINE MANIPULATOR HAD BEEN BROKEN AT SOME POINT DURING THE INITIAL CASE AND THE LOWER PART OF THE CUP AND THE BALLOON WERE LEFT INSIDE. THIS HAS HAPPENED AT ANOTHER HOSPITAL WITHIN OUR SYSTEM.¿. AFTER FURTHER ASSESSMENT IT WAS FOUND, THE 2ND SURGERY TO RETRIEVE THE DEVICE FRAGMENT TOOK PLACE ON 3NOV22. CLARIFICATION OF ¿THIS HAPPENED AT ANOTHER HOSPITAL WITHIN OUR SYSTEM¿ REVEALED THERE WAS NO 2ND INCIDENT INVOLVING A VCARE, "NO INCIDENT IT WAS STATED THAT WE USE THIS SYSTEM AT OTHER FACILITIES WITHIN OUR HOSPITAL SYSTEM.". IT IS UNKNOWN IF THERE WAS PROLONG

  Patient problems: Foreign Body In Patient

  MAUDE report 17446241 ↗
• MalfunctionJul 17, 2023Break

  RETAINED FOREIGN BODY. THE PATIENT REPRESENTED TO THE OFFICE AFTER HAVING A CT THAT DEMONSTRATED RETAINED CUP OF VAGINAL MANIPULATOR THAT WAS USED AT THE TIME OF HER SUPRACERVICAL HYSTERECTOMY AND UNDERWENT EXAM UNDER ANESTHESIA AND REMOVAL OF FOREIGN OBJECT THIS MORNING. IT'S APPARENT THAT THE UTERINE MANIPULATOR HAD BEEN BROKEN AT SOME POINT DURING THE INITIAL CASE AND THE LOWER PART OF THE CUP AND THE BALLOON WERE LEFT INSIDE. THIS HAS HAPPENED AT ANOTHER HOSPITAL WITHIN OUR SYSTEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 17331927 ↗
• MalfunctionJul 13, 2023Unintended Movement; Unintended Movement

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 60-6085-202A, VCARE 200A, LARGE WAS BEING USED DURING A HYSTERECTOMY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿VCARE HANDLE CAME LOOSE AND WAS NOT ABLE TO MANIPULATE THE UTERUS PROPERLY.¿ THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO 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 17319649 ↗
• MalfunctionJun 12, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-6085-202A, VCARE 200A - LARGE, WAS BEING USED DURING A ROBOTIC ASSISTED HYSTERECTOMY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿VCARE BROKE WHE ATTEMPTING TO PULL THE SPECIMEN, THE BALLOON, AND THE CONE, RETRIEVED FROM PATIENT.¿ IT WAS ALSO REPORTED ¿LARGE VCARE CONE AND BALLOON BROKE WHILE DOCTOR WAS ATTEMPTING TO PULL OF SPECIMEN, DOCTOR OBTAINED THE CONE AND BALLOON FROM INSIDE THE PATIENT. ALL PIECES OF THE LARGE VCARE APPEAR TO BE OBTAINED, NO ADDITIONAL PIECES FOUND IN THE ABDOMEN BY DOCTOR.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 17105215 ↗