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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; HYSTEROSCOPE, GYNECOLOGY
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; HYSTEROSCOPE, GYNECOLOGY Back to Search Results
Model Number A22001A
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2024
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the hysteroscope's locating pin was missing.The issue occurred during preparation for use for an unspecified therapeutic procedure.The procedure was completed with a similar device.There were no reports of patient harm.
 
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Brand Name
TELESCOPE, 12°, 4 MM
Type of Device
HYSTEROSCOPE, GYNECOLOGY
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 Key19173450
MDR Text Key340977372
Report Number9610773-2024-01092
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 Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22001A
Device Lot Number586685
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2024
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/11/2010
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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