n.a. 27178ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551081419), received between Nov 5, 2024 and Jan 29, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryJan 29, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE UROLOGIST WAS ATTEMPTING TO CUT A SUTURE ON A PREVIOUS UROLIFT IMPLANT ON (B)(6) 2024. A SNAP WAS HEARD AND A SMALL CRESCENT SHAPED PIECE OF THE MOVING PART ON THE SCISSOR BROKE OFF. IT WAS VERY SMALL AND THE UROLOGIST SPENT AT LEAST AN HOUR INSPECTING ALL AREAS OF THE BLADDER AND URETHRA TO LOCATE THE PIECE THAT BROKE OFF THE FLEXIBLE SCISSORS. HE USED THE 30* LENS, 70* LENS AND A FLEXIBLE CYSTOSCOPE TO THOROUGHLY INSPECT THE BLADDER AND URETHRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270383 ↗
• InjuryNov 5, 2024Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE UROLOGIST WAS ATTEMPTING TO CUT A SUTURE ON A PREVIOUS UROLIFT IMPLANT ON (B)(6) 2024. A SNAP WAS HEARD AND A SMALL CRESCENT SHAPED PIECE OF THE MOVING PART ON THE SCISSOR BROKE OFF. IT WAS VERY SMALL AND THE UROLOGIST SPENT AT LEAST AN HOUR INSPECTING ALL AREAS OF THE BLADDER AND URETHRA TO LOCATE THE PIECE THAT BROKE OFF THE FLEXIBLE SCISSORS. HE USED THE 30* LENS, 70* LENS AND A FLEXIBLE CYSTOSCOPE TO THOROUGHLY INSPECT THE BLADDER AND URETHRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611159 ↗