n.a. 27072ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551079157), received between Jun 6, 2018 and Mar 3, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT A BIOPSY FORCEPS BROKE WHILE BEING USED BY THE SURGEON DURING A PROCEDURE. THE SCREW AT THE TIP OF THE FORCEPS BECAME DETACHED AND FELL INTO THE PATIENT'S BLADDER. THE METAL FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498293 ↗
• MalfunctionSep 8, 2025Break; Material Fragmentation; Detachment of Device or Device Component; Break; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE JAWS BROKE AND LOCKING RING PIN DETACHED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993913 ↗
• InjuryJun 18, 2024Material Fragmentation; Mechanical Problem; Use of Device Problem; Material Fragmentation; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A CYSTOSCOPE WITH BIOPSY WITH CYSVIEW AND URETEROSCOPY PROCEDURE ON (B)(6) 2024, A PIECE OF THE INSTRUMENT BROKE AND FELL INTO THE PATIENT'S BLADDER. THEY SPENT ROUGHLY 10 MINUTES TRYING TO LOCATE THE BROKEN PIECE, BUT WERE UNABLE TO LOCATE IT. THERE WAS NO DIRECT PATIENT INJURY REPORTED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19563593 ↗
• InjuryJun 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CYSTOSCOPE WITH BIOPSY WITH CYSVIEW AND URETEROSCOPY PROCEDURE ON (B)(6) 2024, A PIECE OF THE INSTRUMENT BROKE AND FELL INTO THE PATIENT'S BLADDER. THEY SPENT ROUGHLY 10 MINUTES TRYING TO LOCATE THE BROKEN PIECE, BUT WERE UNABLE TO LOCATE IT. THERE WAS NO DIRECT PATIENT INJURY REPORTED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19563485 ↗
• MalfunctionApr 18, 2023Break; Break

  THE EVENT OCCURRED IN GREAT BRITAIN. IT WAS REPORTED THAT THE INSTRUMENT FAILED DURING USE. A RIVET FELL OUT. THE RIVET WAS RETRIEVED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761493 ↗
• MalfunctionApr 18, 2023Break; Break

  THE EVENT OCCURRED IN GREAT BRITAIN. IT WAS REPORTED THAT THE INSTRUMENT FAILED DURING USE. A RIVET FELL OUT. THE RIVET WAS RETRIEVED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761420 ↗
• MalfunctionNov 24, 2020Connection Problem; Connection Problem

  ALLEGEDLY, PER THE CUSTOMER DURING A UROLOGY PROCEDURE A SCREW OR RIVET ON THE JAW BROKE OFF IN THE PATIENTS BLADDER. THE PIECE WAS RETRIEVED, THE PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTION REQUIRED OR HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10891272 ↗
• MalfunctionSep 3, 2020Material Twisted/Bent; Material Twisted/Bent

  ALLEGEDLY, PER THE CUSTOMER DURING A BLADDER STONE PROCEDURE THE FORCEPS CUP BENT AND WOULD NOT OPEN. PER THE CUSTOMER "WE BROKE CUP TO REMOVE FROM SHEATH", NOTHING FELL INSIDE THE PATIENT AND PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTION REQUIRED OR HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; Unspecified Kidney or Urinary Problem

  MAUDE report 10487715 ↗
• MalfunctionJun 6, 2018Material Separation; Material Separation

  ALLEGEDLY, A RIVET HOLDING THE BIOPSY CUP JAW FELL OUT DURING A UROLOGICAL PROCEDURE IN WHICH THE PATIENT SUSTAINED A MINOR INJURY (LACERATION), REQUIRING A CATHETER UNTIL THE LACERATION COULD HEAL.

  Patient problems: Laceration(s)

  MAUDE report 7575514 ↗