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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 Type  malfunction  
Event Description
The customer reported to olympus, the hysteroscope's light post broke off inside the light cord.The issue was found during reprocessing.There were no reports of patient harm.
 
Manufacturer Narrative
The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
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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 Key18398332
MDR Text Key331672345
Report Number9610773-2023-03772
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 Administrator/Supervisor
Type of Report Initial
Report Date 12/27/2023
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 NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/11/2023
Initial Date FDA Received12/27/2023
Was Device Evaluated by Manufacturer? No
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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