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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 TELESCOPE
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, 4 MM; RIGID TELESCOPE Back to Search Results
Model Number A22002A
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The dhr showed that the device was manufactured according to valid instructions and met all specifications.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.
 
Event Description
The customer reported that during preparation for use, the rigid telescope was found to have a ¿cracked eyepiece¿.No death or injury and no impact to patient or other has been reported.
 
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Brand Name
TELESCOPE, 30°, 4 MM
Type of Device
RIGID TELESCOPE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, de 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 Key17262827
MDR Text Key318605589
Report Number9610773-2023-01802
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K897003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22002A
Device Catalogue NumberA22002A
Device Lot Number664726
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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