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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM Back to Search Results
Model Number A22001A
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed, the image was blurry due to damaged internal lens.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
 
Event Description
The customer reported to olympus, the telescope, 12°, 4 mm had a shattered internal columnar glass.There were no reports of patient injury or medical intervention associated with this event.
 
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Brand Name
TELESCOPE, 12°, 4 MM
Type of Device
TELESCOPE, 12°, 4 MM
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 Key18383797
MDR Text Key331482433
Report Number9610773-2023-03742
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020848
UDI-Public04042761020848
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K897003
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 12/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22001A
Device Lot Number630093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2023
Was the Report Sent to FDA? No
Date Manufacturer Received12/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2012
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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