n.a. 26168DMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551096154), received between Feb 1, 2024 and Feb 1, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 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.

• InjuryFeb 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MANIPULATOR RING BROKE OFF AND REMAINED IN THE VAGINA. THE PATIENT PASSED THE PART ON THE TOILET THE NEXT DAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. NEVERTHELESS, THE RISK OF INTERNAL INJURIES AND INFECTION MUST BE TAKEN INTO ACCOUNT AS RELATED TO THIS INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 18624144 ↗
• InjuryFeb 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MANIPULATOR RING BROKE OFF AND REMAINED IN THE VAGINA. THE PATIENT PASSED THE PART ON THE TOILET THE NEXT DAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. NEVERTHELESS, THE RISK OF INTERNAL INJURIES AND INFECTION MUST BE TAKEN INTO ACCOUNT AS RELATED TO THIS INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 18624143 ↗