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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; ENDOSCOPE SHEATH, REUSABLE
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OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; ENDOSCOPE SHEATH, REUSABLE Back to Search Results
Model Number A22040A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2023
Event Type  malfunction  
Event Description
The customer reported to olympus, the inner sheath ceramic tip loose.The issue was found during an unknown event.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned to olympus for evaluation.The device evaluation found ceramic tip detached.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
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Brand Name
INNER SHEATH, FOR 26 FR. OUTER SHEATH
Type of Device
ENDOSCOPE SHEATH, REUSABLE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18204671
MDR Text Key328983872
Report Number9610773-2023-03382
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761029339
UDI-Public04042761029339
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K931995
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22040A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2023
Was the Report Sent to FDA? No
Date Manufacturer Received11/07/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
STANDARDS.
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