VCARE SMALL 60-6085-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30653405061797), received between Jan 11, 2016 and Jul 17, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K071907); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2017Detachment Of Device Component; Detachment Of Device Component

  THE USER FACILITY REPORTED ITEM 60-6085-200 V-CARE "FELL OFF INSIDE THE PATIENT" DURING A LAPAROSCOPIC HYSTERECTOMY AND HAD TO BE RETRIEVED BY SCOPE. THE PART THAT FELL OFF WAS DESCRIBED AS THE "ENLARGED CIRCLE PART WITH THE LETTER S ON IT". ADDITIONAL INFORMATION WAS ACQUIRED AND THIS MALFUNCTION TOOK PLACE AT THE END OF THE PROCEDURE WHEN THE UTERUS WAS BEING REMOVED VAGINALLY. THE FORWARD CUP WAS NOT SUTURED TO THE CERVIX. THE PROCEDURE WAS COMPLETED, HOWEVER THIS INCIDENT CAUSED A TWENTY-MINUTE DELAY. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY IF IT WERE TO RECUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6716782 ↗
• MalfunctionJan 26, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED BY THE USER FACILITY, DURING A LAPAROSCOPIC ABDOMINAL HYSTERECTOMY ON B)(6) 2017 A "VCARE WAS USED ON A PATIENT AND UPON REMOVING DEVICE FROM THE PATIENT'S UTERUS IT BROKE INTO THREE (3) PIECES." FURTHER INFORMATION FROM THE FACILITY REVEALED THAT THE VCARE CAME APART AT THE END OF THE PROCEDURE AS THEY WERE REMOVING THE UTERUS FROM THE PATIENT. "THE GREEN CUP DETACHED AND WAS INSIDE THE PATIENT. THE SURGEON RETRIEVED THE GREEN CUP FROM INSIDE THE PATIENT." ALL THREE (3) PIECES WERE RETRIEVED AND VERIFIED BY THE SURGEON. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY. THIS INCIDENT IS BEING REPORTED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6279985 ↗
• MalfunctionOct 25, 2016Break

  THE USER FACILITY REPORTED THAT DURING USE OF THE VCARE UTERINE MANIPULATOR ON (B)(6) 2016 IN A HYSTERECTOMY PROCEDURE, "THE SMALL VCARE DEVICE FELL APART." AS REPORTED, "THE BALLOON CAME OFF THE SHAFT AND BOTH THE FORWARD GREEN CUP AND THE OCCLUDE CUP CAME OFF (SLIDE OFF) THE SHAFT" WHEN THE DEVICE WAS COMING OUT OF THE PATIENT DURING THE REMOVAL PROCESS. ALL PARTS WERE RECOVERED WITH NO PROBLEMS REPORTED. NO ALTERNATE DEVICE WAS USED AND THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS, SURGICAL DELAY OR PATIENT INJURY. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6055410 ↗
• MalfunctionJun 17, 2016Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING USE OF A CONMED VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR IN A GYNECOLOGICAL PROCEDURE THE TIP CAME OFF THE MANIPULATOR DURING THE PROCEDURE. THE DEVICE COMPONENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS, SURGICAL DELAY OR PATIENT INJURY. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING PATIENT DEMOGRAPHIC'S (AGE, WEIGHT) OR THE PATIENT'S LATEST CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5731904 ↗
• MalfunctionMay 31, 2016Detachment Of Device Component

  THE USER FACILITY REPORTED THAT DURING USE OF A CONMED VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR IN A ROBOTIC HYSTERECTOMY THE BALLOON AND GREEN FORWARD CUP CAME OFF THE MANIPULATOR INSIDE THE PATIENT'S ABDOMINAL CAVITY DURING THE PROCEDURE. THE SURGEON HAD TO RETRIEVE THE CUP AND BALLOON WITH A SPECIMEN BAG. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS, SURGICAL DELAY OR PATIENT INJURY. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EVENT HAS OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5688487 ↗
• Jan 11, 2016Material Separation

  THE USER FACILITY REPORTED DURING USE OF A VCARE UTERINE MANIPULATOR IN A TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2015 AND WHILE REMOVING THE UTERUS, THE VCARE DEVICE FELL APART. ALL OF THE PARTS WERE LOCATED AND REMOVED. THE INTRAUTERINE BALLOON HAD ALSO COME OFF AND WAS FOUND ON THE OR TABLE. AS REPORTED, THE PROCEDURE WAS ALMOST OVER WHEN THE REPORTED PROBLEM OCCURRED; THUS, ANOTHER DEVICE WAS NOT NEEDED TO FINISH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL DELAY OR PATIENT INJURY. THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR INDICATION THAT ANY LONG TERM ADVERSE EFFECT HAVE OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5357552 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071907. One submission often covers many models, so check the product and lot details in each record.

• Z-1520-2011 · Feb 2, 2011 · Terminated
  VCare Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5" x 12"
• Z-0176-2009 · Sep 8, 2008 · Terminated
  VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60-6085-001. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VCARE Re
• Z-0175-2009 · Sep 8, 2008 · Terminated
  VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF 60-6085-000. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VC
• Z-0177-2009 · Sep 8, 2008 · Terminated
  VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF 60-6085-002. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VCARE