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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE; RIGID VIDEO LAPAROSCOPE
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OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE; RIGID VIDEO LAPAROSCOPE Back to Search Results
Model Number WA50012A
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2024
Event Type  malfunction  
Event Description
It was observed that during the device evaluation, the telescope exhibited a green image on the screen.There were no reports of patient involvement.
 
Manufacturer Narrative
The device was returned and the evaluation found that the screen was green and had horizontal stripes due to a defective outer tube, the video cable was wrinkled and damaged and the protector was damaged.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE
Type of Device
RIGID VIDEO LAPAROSCOPE
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 Key18889114
MDR Text Key337805697
Report Number9610773-2024-00691
Device Sequence Number1
Product Code NWB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWA50012A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2013
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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