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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; RIGID ENDOSCOPE SHEATH
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OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RIGID ENDOSCOPE SHEATH Back to Search Results
Model Number A22040A
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was observed that during the device inspection, the rigid endoscope sheath exhibited a scratch on the inside of the tip beak.There were no reports of patient involvement.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
INNER SHEATH, FOR 26 FR. OUTER SHEATH
Type of Device
RIGID ENDOSCOPE SHEATH
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18944036
MDR Text Key339092982
Report Number9610773-2024-00804
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761029339
UDI-Public04042761029339
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K931995
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberA22040A
Device Lot Number056W-0054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/16/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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