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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BAAN: TELESCOPE, 4 MM, 30°, AUTOCLAV
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OLYMPUS WINTER & IBE GMBH BAAN: TELESCOPE, 4 MM, 30°, AUTOCLAV Back to Search Results
Model Number A1932A
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2024
Event Type  malfunction  
Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, the telescope, 4 mm, 30°, autoclave connector was broken.The issue occurred during maintenance.There were no reports of patient harm.
 
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Brand Name
BAAN: TELESCOPE, 4 MM, 30°, AUTOCLAV
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 Key19126616
MDR Text Key340974284
Report Number9610773-2024-01042
Device Sequence Number1
Product Code FDC
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K992141
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/17/2024
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 NumberA1932A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/15/2024
Initial Date FDA Received04/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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