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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; GYNECOLOGY HYSTEROSCOPE
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; GYNECOLOGY HYSTEROSCOPE Back to Search Results
Model Number A22001A
Device Problems Break (1069); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was observed that during the device inspection, the gynecology hysteroscope exhibited the internal lens had a crack and the eye piece was loose.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
TELESCOPE, 12°, 4 MM
Type of Device
GYNECOLOGY HYSTEROSCOPE
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 Key18968267
MDR Text Key339220241
Report Number9610773-2024-00837
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020848
UDI-Public04042761020848
Combination Product (y/n)N
Reporter Country CodeBG
PMA/PMN Number
K897003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberA22001A
Device Lot Number664346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/25/2014
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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