NA 8654282Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207018781), received between Sep 6, 2019 and Oct 11, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CYSTOSCOPY AND HOLEP PROCEDURE, "IT WAS NOTED THAT THE LONG METAL LASER BRIDGE HAD BECOME SEPARATED FROM THE REMAINDER OF THE HAND PIECE OF THE LASER WORKING ELEMENT. IT WAS IDENTIFIED IMMEDIATELY, AND THE LASER METAL BRIDGE WAS ABLE TO BE REMOVED INTACT. THERE WAS NO PART OF THE INSTRUMENT THAT WAS RETAINED. THERE WAS A SMALL DEFECT NOTED IN THE POSTERIOR WALL OF THE BLADDER THAT WAS PRESUMED TO BE FROM THE TIP OF THE LASER BRIDGE THAT HAD BECOME DETACHED. THE DEFECT WAS LESS THAN 0.5CM WHICH WAS INSPECTED WITH A CYSTOGRAM AND REPAIRED." "A 3-WAY FOLEY WAS PLACED WITH CONTINUOUS BLADDER IRRIGATION INFUSING. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT SIGNIFICANT BLOOD LOSS AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE PATIENT WAS DISCHARGED HOME WITH THE FOLEY CATHETER IN PLACE AND FOLLOW-UP SCHEDULED WITH THE UROLOGY OFFICE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture

  MAUDE report 20427156 ↗
• InjuryOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CYSTOSCOPY AND HOLEP PROCEDURE, "IT WAS NOTED THAT THE LONG METAL LASER BRIDGE HAD BECOME SEPARATED FROM THE REMAINDER OF THE HAND PIECE OF THE LASER WORKING ELEMENT. IT WAS IDENTIFIED IMMEDIATELY, AND THE LASER METAL BRIDGE WAS ABLE TO BE REMOVED INTACT. THERE WAS NO PART OF THE INSTRUMENT THAT WAS RETAINED. THERE WAS A SMALL DEFECT NOTED IN THE POSTERIOR WALL OF THE BLADDER THAT WAS PRESUMED TO BE FROM THE TIP OF THE LASER BRIDGE THAT HAD BECOME DETACHED. THE DEFECT WAS LESS THAN 0.5CM WHICH WAS INSPECTED WITH A CYSTOGRAM AND REPAIRED." "A 3-WAY FOLEY WAS PLACED WITH CONTINUOUS BLADDER IRRIGATION INFUSING. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT SIGNIFICANT BLOOD LOSS AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE PATIENT WAS DISCHARGED HOME WITH THE FOLEY CATHETER IN PLACE AND FOLLOW-UP SCHEDULED WITH THE UROLOGY OFFICE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture

  MAUDE report 20427024 ↗
• MalfunctionSep 6, 2019Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  ON AUGUST 7TH 2019, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): DURING PROCEDURE, LASER GUIDE LOOPS ARE NOT STAYING CONNECTED DURING USE. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? NO. HOW WAS THE PATIENT ANESTHETIZED? GENERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8972604 ↗