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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 Problems Corroded (1131); Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was observed during the device inspection, that the telescope exhibited scratches on the tip objective lens and there was corrosion on the insertion part outer tube.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
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 Key19182437
MDR Text Key341790383
Report Number9610773-2024-01103
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020848
UDI-Public04042761020848
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K897003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/25/2024
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 Other
Device Model NumberA22001A
Device Lot Number604032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/16/2024
Initial Date FDA Received04/25/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/12/2010
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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