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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2024
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 gynecology hysteroscope had broken glass at the tube.This issue occurred during preparation for use of an unknown diagnostic procedure.There were no reports of patient harm or injury.
 
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Brand Name
TELESCOPE, 12°, 4 MM
Type of Device
GYNECOLOGY HYSTEROSCOPE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrsse 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 Key18982961
MDR Text Key338807728
Report Number9610773-2024-00872
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020848
UDI-Public04042761020848
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K897003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/26/2024
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 Health Professional
Device Model NumberA22001A
Device Lot Number693842
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received03/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/03/2015
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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