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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°, NTSC, HD COMPATIBLE, AUTOCLAVABLE; RIGID VIDEO SCOPE

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OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, NTSC, HD COMPATIBLE, AUTOCLAVABLE; RIGID VIDEO SCOPE Back to Search Results
Model Number WA50013A
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
H10: e2: health professional ¿ (blank) and e3: occupation ¿ no information provided.The device is expected to be returned for evaluation but has not yet been received.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
 
Event Description
It was reported that the subject device image was dark.There were no reports of patient involvement.
 
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Brand Name
VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, NTSC, HD COMPATIBLE, AUTOCLAVABLE
Type of Device
RIGID VIDEO SCOPE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19214961
MDR Text Key341852971
Report Number9610773-2024-30243
Device Sequence Number1
Product Code NWB
UDI-Device Identifier04042761061957
UDI-Public04042761061957
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K090980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/30/2024
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 Health Professional
Device Model NumberWA50013A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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