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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; RIGID ENDOSCOPE SHEATH
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OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; RIGID ENDOSCOPE SHEATH Back to Search Results
Model Number A42011A
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2024
Event Type  malfunction  
Event Description
It was observed that during the device inspection, the rigid endoscope sheath exhibited a crack on the ceramic tip.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
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
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 Key19060924
MDR Text Key340460044
Report Number9610773-2024-00975
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761023658
UDI-Public04042761023658
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/08/2024
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 Other
Device Model NumberA42011A
Device Lot Number20314
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/08/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/24/2020
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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