Single use Surgical Optical Fiber OFH302721Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033945938284), received between Jan 28, 2020 and May 22, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K180158); they may or may not involve this specific model.

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 18, 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.

• MalfunctionMay 22, 2020Therapeutic or Diagnostic Output Failure

  THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10082907 ↗
• MalfunctionFeb 3, 2020Break

  DURING LASER LITHOTRIPSY THE EMPOWER LASER FIBER WIRE SNAPPED. IT BROKE AT THE ENTRY POINT OF THE FLEXIBLE URETEROSCOPE. ANOTHER FIBER WIRE WAS SUPPLIED AND THE EXACT EVENT HAPPENED AT THE SAME POINT OF ENTRY. IT WAS NOTICED THAT BOTH FIBER WIRES WERE THE SAME REFERENCE AND LOT NUMBER. A THIRD LASER FIBER WIRE WAS SUPPLIED THAT WAS THE SAME 200 SERIES BUT A DIFFERENT REFERENCE AND LOT NUMBER. IT DID NOT SNAP THOUGH IT WAS NOTICED THAT THE FIBER WIRE WAS NOT LIGHTING UP WITH THE GREEN BEAM AT THE END OF THE FIBER AS IT SHOULD. CHARGE RN NOTIFIED THAT ALL 200 SERIES WIRES WILL BE GONE THROUGH AND ANY WITH THE SAME REFERENCE AND LOT NUMBER AS THE DEFECTIVE FIBERS AND WILL BE PLACED IN MATERIAL BIN WITH A NOTE AS TO WHY. THE EFFECTED WIRES FROM THIS EVENT WERE SENT TO CLINICAL ENGINEERING AND EXAMINED UNDER A MICROSCOPE. THE LASER FIBERS WILL BE RETURNED TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9659279 ↗
• MalfunctionJan 28, 2020Break; Thermal Decomposition of Device

  EMPOWER STERILE SURGICAL LASER FIBER BROKE IN HALF WHERE IT ENTERED THE FLEXIBLE URETEROSCOPY SCOPE. AFTER IT BROKE IT LANDED ON THE DRAPE AND BURNED A TINY HOLE IN DRAPE. NO HARM WAS CAUSED TO THE PATIENT. NO HARM WAS CAUSED TO ANY OF THE STAFF. BOTH PIECES OF THE LASER FIBER WERE KEPT AND TURNED IN. FIBER WILL BE RETURNED BY SITE STAFF FOR FAILURE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9636380 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180158. One submission often covers many models, so check the product and lot details in each record.

• Z-1842-2021 · Apr 27, 2021 · Terminated
  Olympus Sterile Optical Laser Fiber, single use and reusable