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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, WIDEANGLE, 4 MM; RIGID SCOPE
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, WIDEANGLE, 4 MM; RIGID SCOPE Back to Search Results
Model Number A22005A
Device Problem Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  malfunction  
Manufacturer Narrative
The device was returned and the evaluation found the following: moisture found; outer tube had corrosion and it was bent; internal lester was burned; and there were foreign debris in optical system.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, the rigid scope was burned.The issue occurred during the preparation for use.There were no reports of patient harm.
 
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Brand Name
TELESCOPE, 30°, WIDEANGLE, 4 MM
Type of Device
RIGID SCOPE
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 Key18780348
MDR Text Key336242256
Report Number9610773-2024-00536
Device Sequence Number1
Product Code HIH
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 User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22005A
Device Lot Number720063A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2024
Was the Report Sent to FDA? No
Date Manufacturer Received01/31/2024
Was Device Evaluated by Manufacturer? Yes
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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