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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE Back to Search Results
Model Number A4674A
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
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 that during the device inspection, the telescope exhibited that the eyepiece was scratched.There were no reports of patient involvement.
 
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Brand Name
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
Type of Device
RIGID ENDOSCOPE TELESCOPE
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 Key18935923
MDR Text Key338437349
Report Number9610773-2024-00779
Device Sequence Number1
Product Code GCP
UDI-Device Identifier04042761006361
UDI-Public04042761006361
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K904939
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA4674A
Device Lot Number663079
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/30/2014
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 VISERA ELITE VIDEO SYSTEM CENTER
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