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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2024
Event Type  malfunction  
Event Description
It was reported the rigid endoscope sheath ceramic tip was broken.The issue occurred during reprocessing.There were no reports of patient harm or injury.
 
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 Key19154916
MDR Text Key340969618
Report Number9610773-2024-01076
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 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22040A
Device Lot Number174W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/11/2024
Initial Date FDA Received04/22/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2017
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
S190.
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