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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2024
Event Type  malfunction  
Event Description
It was reported the telescope was broken.There were no reports of patient harm.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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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 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 Key19096195
MDR Text Key340811831
Report Number9610773-2024-01011
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020855
UDI-Public04042761020855
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K897003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22002A
Device Lot Number599242
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2024
Was the Report Sent to FDA? No
Date Manufacturer Received02/25/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2009
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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