n.a. 27074BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551079386), received between Dec 9, 2019 and Aug 4, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, AFTER FIRST USE, THE JAWS WERE BROKEN EASILY. ACCORDING TO THE AVAILABLE PICTURE, THE PIN OF THE JOINT AND A PIECE NEAR THE PIN ARE BROKEN OFF. NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708608 ↗
• MalfunctionAug 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, AFTER FIRST USE, THE JAWS WERE BROKEN EASILY. ACCORDING TO THE AVAILABLE PICTURE, THE PIN OF THE JOINT AND A PIECE NEAR THE PIN ARE BROKEN OFF. NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701286 ↗
• MalfunctionApr 22, 2025Break; Device Handling Problem; Break; Device Handling Problem

  IT WAS REPORTED THAT THE BASE OF THE JAWS BROKE AT THE PREPARATION FOR THE FIRST USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887094 ↗
• InjuryApr 18, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A STONE CRUSHING FORCEPS WOULD NOT CLOSE AFTER A STONE WAS LODGED INSIDE THE JAWS. THIS MEANT THAT THE INSTRUMENT COULDN'T BE REMOVED FROM THE SHEATH DURING A CYSTOSCOPY. THE SURGEON HAD TO REVERT TO AN OPEN PROCEDURE TO FREE THE STONE FROM THE INSTRUMENT SO THAT IT COULD BE SAFELY PASSED BACK THROUGH THE CYSTOSCOPY SHEATHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139743 ↗
• InjuryApr 18, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A STONE CRUSHING FORCEPS WOULD NOT CLOSE AFTER A STONE WAS LODGED INSIDE THE JAWS. THIS MEANT THAT THE INSTRUMENT COULDN'T BE REMOVED FROM THE SHEATH DURING A CYSTOSCOPY. THE SURGEON HAD TO REVERT TO AN OPEN PROCEDURE TO FREE THE STONE FROM THE INSTRUMENT SO THAT IT COULD BE SAFELY PASSED BACK THROUGH THE CYSTOSCOPY SHEATHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139742 ↗
• MalfunctionNov 2, 2021Break; Break

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): THE EVENT OCCURRED IN (B)(6). DURING PATIENT TREATMENT, THE JAW MECHANISM BROKE APART INSIDE THE PATIENT. THE SURGEON THEN NEEDED TO INVESTIGATE TO FIND A FRAGMENT AND X-RAY TO ENSURE NO OTHER FRAGMENTS WERE LEFT IN THE PATIENT. NO FURTHER FRAGMENTS WERE DETECTED, AND THE X-RAY WAS CLEAR. THE OPERATION WAS EXTENDED FOR 1.5 HOURS. (MFR'S. INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Insufficient Information

  MAUDE report 12738669 ↗
• MalfunctionMay 28, 2020Material Separation; Material Separation

  AS PER AN AER FROM (B)(6) RECEIVED BY THE FACTORY IN (B)(6): BREAKAGE OF THE CLAMP IN THE PATIENT'S BLADDER. EXTENSION OF THE INTERVENTION FOR RECOVERY OF THE BROKEN PART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10097641 ↗
• MalfunctionJan 15, 2020Material Separation; Material Separation

  ALLEGEDLY, DURING A CYSTOLITHOTRIPSY AND CYSTOLITHOLAPAXY PROCEDURE, A PIECE, OR PIECES, OF THE FORCEPS BROKE OFF INTO THE PATIENT. THEY RETRIEVED THE PIECE(S) AND PROCEDURE WAS COMPLETED WITH NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593884 ↗
• MalfunctionDec 9, 2019Break

  STONE CRUSHER AND BIOPSY FORCEP NOTED TO BE BROKEN DURING CYSTOLITHOTRIPSY AND CYSTOLITHOLAPAXY PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9436902 ↗