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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE
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OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE Back to Search Results
Model Number A70940A
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned, and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was observed that during the device evaluation, the telescope "trueview ii", 4 mm, 0°, autoclavable exhibited that the objective lens was cracked.There were no reports of patient involvement.
 
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Brand Name
TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE
Type of Device
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 Key18838363
MDR Text Key337805719
Report Number9610773-2024-00620
Device Sequence Number1
Product Code HRX
UDI-Device Identifier04042761010535
UDI-Public04042761010535
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K950076
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 03/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberA70940A
Device Lot Number403697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2024
Was the Report Sent to FDA? No
Date Manufacturer Received02/29/2024
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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