VCARE DX 60-6080-000ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653405003717), received between Apr 20, 2021 and Jul 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-6080-000A, VCARE DX, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿UTERINE PERFORATION OCCURRED DURING DEVICE INSERTION CAUSED BY TOO MUCH MANIPULATOR RIGIDITY AND LOW UTERINE MOBILITY. NOT VERY VERSATILE DEVICE.¿. THERE WAS NO INITIAL REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. FURTHER ASSESSMENT QUESTIONS HAVE BEEN SENT TO THE REPORTER FOR FOLLOW UP; HOWEVER, TO DATE WE HAVE NOT RECEIVED A RESPONSE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF UTERINE PERFORATION DURING THE PROCEDURE. UPDATED INFORMATION RECEIVED 26JUL23: THE CUSTOMER REPORTED THAT THE DEVICE, 60-6080-000A, VCARE DX, WAS BEING USED DURING A VL ADNEXECTOMY-OVARIAN CYST VL PROCEDURE ON (B)(6) 2023. THE CLIENT CLAIMS THAT THE END OF THE MANIPULATOR IS TOO STIFF, AND THIS FEATURE CAN CAUSE DAMAGE TO THE UTERUS (PERFORATION). THE CLIENT WOULD LIKE TO HAVE A SOFT END OF THE UTERUS. UTERINE PERFORATION OCCURRED DURING DEVICE INSERTION CAUSED BY TOO MUCH MANIPULATOR RIGIDITY AND LOW UTERINE MOBILITY. SUTURING OF THE RIGHT LATERAL FUNDUS WAS REQUIRED. NO FURTHER MEDICAL INTERVENTION OR HOSPITAL

  Patient problems: Uterine Perforation

  MAUDE report 17371112 ↗
• InjuryApr 20, 2021Difficult to Insert; Material Too Rigid or Stiff

  DURING DIAGNOSTIC LAPAROSCOPY FOR LEFT CYSTECTOMY UTERUS PERFORATION BY VCARE CANNULA. DIRECT VISUALIZATION OF UTERUS PERFORATION WITH THE LAPAROSCOPE. OPERATOR'S REMARKS "HANDLE IS TOO RIGID AND THE STOPPER DOESN'T PREVENT THE MANIPULATOR FROM GOING IN FURTHER". FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11700846 ↗