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Olympus A20976ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Bridge, one way · Class 2

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761020398), received between Jun 17, 2022 and Jun 17, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Contamination7

Patient problems

  • No Clinical Signs, Symptoms or Conditions7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 17, 2022Contamination; Contamination

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, THE BRIDGE WAS SWIVELING DURING A CASE. AFTER THE PROCEDURE, AT REPROCESSING, IT WAS NOTED THE BRIDGE UNSCREWED APART. THE TWO PIECES OF THE BRIDGE WERE DISMANTLED AND BIOBURDEN, POSSIBLY CRUSTED BLOOD, WAS FOUND IN THE BRIDGE. THE FACILITY TOOK APART THE OTHER SIX (6) BRIDGES AND BIOBURDEN WAS FOUND ON THE OTHER SIX (6) BRIDGES AS WELL. NO PATIENT HARM REPORTED. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14736940 ↗
  • MalfunctionJun 17, 2022Contamination; Contamination

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, THE BRIDGE WAS SWIVELING DURING A CASE. AFTER THE PROCEDURE, AT REPROCESSING, IT WAS NOTED THE BRIDGE UNSCREWED APART. THE TWO PIECES OF THE BRIDGE WERE DISMANTLED AND BIOBURDEN, POSSIBLY CRUSTED BLOOD, WAS FOUND IN THE BRIDGE. THE FACILITY TOOK APART THE OTHER SIX BRIDGES AND BIOBURDEN WAS FOUND ON THE OTHER SIX BRIDGES AS WELL. NO PATIENT HARM REPORTED. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14736586 ↗
  • MalfunctionJun 17, 2022Contamination; Contamination

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, THE BRIDGE WAS SWIVELING DURING A CASE. AFTER THE PROCEDURE, AT REPROCESSING, IT WAS NOTED THE BRIDGE UNSCREWED APART. THE TWO PIECES OF THE BRIDGE WERE DISMANTLED AND BIOBURDEN, POSSIBLY CRUSTED BLOOD, WAS FOUND IN THE BRIDGE. THE FACILITY TOOK APART THE OTHER SIX (6) BRIDGES AND BIOBURDEN WAS FOUND ON THE OTHER SIX (6) BRIDGES AS WELL. NO PATIENT HARM REPORTED. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14736213 ↗
  • MalfunctionJun 17, 2022Contamination; Contamination

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, THE BRIDGE WAS SWIVELING DURING A CASE. AFTER THE PROCEDURE, AT REPROCESSING, IT WAS NOTED THE BRIDGE UNSCREWED APART. THE TWO PIECES OF THE BRIDGE WERE DISMANTLED AND BIOBURDEN, POSSIBLY CRUSTED BLOOD, WAS FOUND IN THE BRIDGE. THE FACILITY TOOK APART THE OTHER SIX BRIDGES AND BIOBURDEN WAS FOUND ON THE OTHER SIX BRIDGES AS WELL. NO PATIENT HARM REPORTED. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14735493 ↗
  • MalfunctionJun 17, 2022Contamination; Contamination

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, THE BRIDGE WAS SWIVELING DURING A CASE. AFTER THE PROCEDURE, AT REPROCESSING, IT WAS NOTED THE BRIDGE UNSCREWED APART. THE TWO PIECES OF THE BRIDGE WERE DISMANTLED AND BIOBURDEN, POSSIBLY CRUSTED BLOOD, WAS FOUND IN THE BRIDGE. THE FACILITY TOOK APART THE OTHER SIX BRIDGES AND BIOBURDEN WAS FOUND ON THE OTHER SIX BRIDGES AS WELL. NO PATIENT HARM REPORTED. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14735404 ↗
  • MalfunctionJun 17, 2022Contamination; Contamination

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, THE BRIDGE WAS SWIVELING DURING A CASE. AFTER THE PROCEDURE, AT REPROCESSING, IT WAS NOTED THE BRIDGE UNSCREWED APART. THE TWO PIECES OF THE BRIDGE WERE DISMANTLED AND BIOBURDEN, POSSIBLY CRUSTED BLOOD, WAS FOUND IN THE BRIDGE. THE FACILITY TOOK APART THE OTHER SIX BRIDGES AND BIOBURDEN WAS FOUND ON THE OTHER SIX BRIDGES AS WELL. NO PATIENT HARM REPORTED. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14735323 ↗
  • MalfunctionJun 17, 2022Contamination; Contamination

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, THE BRIDGE ON THE RIGID CYSTOSCOPE WAS SWIVELING DURING A CASE. AFTER THE PROCEDURE, AT REPROCESSING, IT WAS NOTED THE BRIDGE UNSCREWED APART. THE TWO PIECES OF THE BRIDGE WERE DISMANTLED AND BIOBURDEN, POSSIBLY CRUSTED BLOOD, WAS FOUND IN THE BRIDGE. THE FACILITY TOOK APART THE OTHER SIX (6) BRIDGES AND BIOBURDEN WAS FOUND ON THE OTHER SIX (6) BRIDGES AS WELL. NO PATIENT HARM REPORTED. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14735262 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.