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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; MEDIASTINOSCOPE, SURGICAL
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; MEDIASTINOSCOPE, SURGICAL Back to Search Results
Model Number WA53000A
Device Problems Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Event Description
It was observed that during the device inspection, the telescope exhibited a worn eyepiece and damaged fibers in the distal end.There were no reports of patient involvement.
 
Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE
Type of Device
MEDIASTINOSCOPE, SURGICAL
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 Key18992717
MDR Text Key339127270
Report Number9610773-2024-00884
Device Sequence Number1
Product Code EWY
UDI-Device Identifier04042761052757
UDI-Public04042761052757
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K950076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberWA53000A
Device Lot Number695303
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/20/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/22/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
OTV-S190
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