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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 70°, 4 MM
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 70°, 4 MM Back to Search Results
Model Number A22003A
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2023
Event Type  malfunction  
Event Description
The customer reported to olympus that the telescope, 70°, 4 mm was cracked.The event occurred during reprocessing for a diagnostic procedure.There was no patient harm associated with the event.
 
Manufacturer Narrative
The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
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Brand Name
TELESCOPE, 70°, 4 MM
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 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18309576
MDR Text Key330262438
Report Number9610773-2023-03600
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020862
UDI-Public04042761020862
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 12/12/2023
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 NumberA22003A
Device Lot Number618667
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/27/2023
Initial Date FDA Received12/12/2023
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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