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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, 4 MM; RIGID ENDOSCOPE TELESCOPE
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, 4 MM; RIGID ENDOSCOPE TELESCOPE Back to Search Results
Model Number A22002A
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2024
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 rigid endoscope telescope's lens was damaged with displacement.There were no reports of patient involvement.
 
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Brand Name
TELESCOPE, 30°, 4 MM
Type of Device
RIGID ENDOSCOPE TELESCOPE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg/de/germany 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg/de/germany 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19020135
MDR Text Key339259269
Report Number9610773-2024-00926
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020855
UDI-Public04042761020855
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K897003
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 04/02/2024
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 NumberA22002A
Device Lot Number695516
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/31/2024
Initial Date FDA Received04/02/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/23/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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