Single use Surgical Optical Fiber EMP-FBX272HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08033945938420), received between Jun 5, 2019 and Feb 23, 2021 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364865 ↗
• MalfunctionFeb 19, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347736 ↗
• MalfunctionDec 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10948280 ↗
• MalfunctionSep 2, 2020Optical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10481202 ↗
• MalfunctionAug 6, 2020Detachment of Device or Device Component; Therapeutic or Diagnostic Output Failure; Detachment of Device or Device Component

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

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

  MAUDE report 10373645 ↗
• MalfunctionMar 20, 2020Defective Component

  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 9860696 ↗
• MalfunctionFeb 5, 2020Therapeutic or Diagnostic Output Failure; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Blister; No Known Impact Or Consequence To Patient

  MAUDE report 9671490 ↗
• MalfunctionJan 8, 2020Defective Component

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9564197 ↗
• MalfunctionOct 29, 2019Therapeutic or Diagnostic Output Failure; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

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

  MAUDE report 9248766 ↗
• MalfunctionSep 11, 2019Output Problem

  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 8992490 ↗
• MalfunctionAug 9, 2019Defective Device

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8878275 ↗
• MalfunctionAug 1, 2019Output Problem

  THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. IT WAS USED WITH EMPOWER H65 LASER (SERIAL NUMBER:(B)(4)). NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8850490 ↗
• MalfunctionJul 24, 2019Therapeutic 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 8820550 ↗
• MalfunctionJul 24, 2019Electrical /Electronic Property Problem

  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 8820548 ↗
• MalfunctionJun 5, 2019Therapeutic 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 8669692 ↗