ProFlex DSU273PFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816959020699), received between May 12, 2017 and May 25, 2017 — classified as 3 malfunctions.

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

• MalfunctionMay 25, 2017Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE LASER FIBER BROKE IN THE SCOPE AND WAS EMBEDDED IN THE TISSUE. THEREFORE, A KUB X-RAY WAS USED TO DETERMINE IF THERE WAS NO EXTRAGATION. THE LUMENIS LASER WAS USED; HOWEVER, THE DORNIER LASER SHOULD HAVE BEEN USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6590168 ↗
• MalfunctionMay 12, 2017Break

  IT WAS REPORTED THAT THE LASER FIBER BROKE OUTSIDE OF THE SCOPE. THE DEVICE WAS REPLACED WITH A NEW LASER FIBER, AND THE PROCEDURE WAS COMPLETED WITH SLIGHT DELAY; HOWEVER, WITHOUT IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6564633 ↗
• MalfunctionMay 12, 2017Break

  IT WAS REPORTED THAT THE LASER FIBER BROKE OUTSIDE OF THE SCOPE. THE DEVICE WAS REPLACED WITH A NEW LASER FIBER, AND THE PROCEDURE WAS COMPLETED WITH SLIGHT DELAY; HOWEVER, WITHOUT IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6564396 ↗