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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, 4 MM; HYSTEROSCOPE (AND ACCESSORIES)
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, 4 MM; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number A22002A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Event Description
It was reported, the telescope glasses were present after a procedure but were missing after the cleaning process.The issue occurred after use of the washing machine.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned, and the evaluation found, that the light guide cover lens was missing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
TELESCOPE, 30°, 4 MM
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
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 Key18896821
MDR Text Key337780271
Report Number9610773-2024-00708
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020855
UDI-Public04042761020855
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K897003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22002A
Device Lot Number631490
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2024
Was the Report Sent to FDA? No
Date Manufacturer Received02/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2012
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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