Single use Surgical Optical Fiber OAF005511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033945933517), received between Mar 24, 2026 and Apr 29, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• MalfunctionApr 29, 2026Insufficient Device Problem Information

  ON (B)(6) 2026, DURING A HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, MULTIPLE DEVICE MALFUNCTIONS WERE OBSERVED INVOLVING THE LASER BLAST SHIELD AND LASER FIBERS. APPROXIMATELY 30 MINUTES INTO THE PROCEDURE, THE BLAST SHIELD BURNED DURING LASER ACTIVATION. THE AFFECTED LASER FIBER (A253220) AND BLAST SHIELD WERE REPLACED. FOLLOWING REPLACEMENT, A SECOND BLAST SHIELD BURNED WITHIN APPROXIMATELY 5 MINUTES OF USE WHILE USING A NEW LASER FIBER (A252725). AS A RESULT, THE PRIMARY LASER SYSTEM WAS REPLACED WITH A LOAN UNIT (SERIAL NUMBER (B)(6). A NEW LASER FIBER (A252726) AND BLAST SHIELD WERE INSTALLED; HOWEVER, THE SAME ISSUE REOCCURRED, WITH THE BLAST SHIELD AGAIN BURNING DURING USE. DUE TO ONGOING BLEEDING AND THE FACT THAT THE PATIENT WAS A (B)(6) WITNESS (BLOOD PRODUCTS CONTRAINDICATED), A SECOND CLINICIAN WAS REQUIRED TO ATTEND IN ORDER TO COMPLETE THE PROCEDURE. THIS RESULTED IN AN APPROXIMATELY 20 MINUTE DELAY WHILE THE SECOND CLINICIAN ATTENDED THE OPERATING LIST. THE PROCEDURE WAS EVENTUALLY COMPLETED BY RESTARTING THE LOAN LASER UNIT (B)(6) WITH A NEW BLAST SHIELD AND A NEW LASER FIBER, AFTER WHICH THE DEVICE FUNCTIONED SUFFICIENTLY TO FINISH THE SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25027129 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER, THE CUSTOMER STATED BELIEVE THE LASER CAUSED EXCESSIVE BLEEDING DURING 2 HOLEPS, WHICH LEAD TO 2 PATIENTS BEING RE-ADMITTED LAST NIGHT FOR BLOOD CLOTS. HE DID REQUEST THAT WE INVESTIGATE FIBER LOT A253165. THIS IS THE SAME LOT THAT WAS USED WHEN MULTIPLE BLAST SHIELDS BLEW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24681602 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER, THE CUSTOMER STATED BELIEVE THE LASER CAUSED EXCESSIVE BLEEDING DURING 2 HOLEPS, WHICH LEAD TO 2 PATIENTS BEING RE-ADMITTED LAST NIGHT FOR BLOOD CLOTS. HE DID REQUEST THAT WE INVESTIGATE FIBER LOT A253165. THIS IS THE SAME LOT THAT WAS USED WHEN MULTIPLE BLAST SHIELDS BLEW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24681594 ↗