SureFlex 8013059Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878953000145), received between Sep 29, 2017 and Sep 29, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Device Output” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2017No Device Output; No Device Output

  IT WAS REPORTED THAT WHILE USING A SURGICAL FIBER DURING A LASER LITHOTRIPSY PROCEDURE, THE AIMING BEAM FROM THE FIBER COULD NO LONGER BE VISUALIZED. THE FIBER WAS REPLACED AND THE PROCEDURE COMPLETED USING A SECOND SURGICAL FIBER. AT THE END OF THE CASE, THE STAFF NOTICED THREE SMALL BURN AREAS ON THE SURGICAL DRAPE, AND IT WAS NOTED THAT AT NO TIME DID THE STAFF SMELL AN ODOR THAT WOULD HAVE INDICATED BURNING AND THERE WAS NO OBSERVATION OF A FLAME NOTED BY THE STAFF. THERE WAS NO PATIENT AND/OR USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6904629 ↗