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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OPTIK, 4MM, 30GW; HYSTERORESECTOSCOPE
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OLYMPUS WINTER & IBE GMBH OPTIK, 4MM, 30GW; HYSTERORESECTOSCOPE Back to Search Results
Model Number A1935A
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2024
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 observed during the device inspection, the light guide connector post of the hysteroresectoscope was missing.There were no reports of patient involvement.
 
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Brand Name
OPTIK, 4MM, 30GW
Type of Device
HYSTERORESECTOSCOPE
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 Key19184820
MDR Text Key341788055
Report Number9610773-2024-01106
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeAS
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
Date FDA Received04/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberA1935A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2024
Was the Report Sent to FDA? No
Date Manufacturer Received04/18/2024
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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