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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 12°, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE, HYSTEROSCOPES
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 12°, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE, HYSTEROSCOPES Back to Search Results
Model Number A4673A
Device Problem Pitted (1460)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Manufacturer Narrative
The device was returned and the evaluation found no additional reportable malfunctions other than those mentioned in b5.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the rigid endoscope telescope's end had a chip.The event was found during reprocessing.There were no reports of patient harm.
 
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Brand Name
TELESCOPE, 3 MM, 12°, AUTOCLAVABLE
Type of Device
RIGID ENDOSCOPE TELESCOPE, HYSTEROSCOPES
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 Key18738062
MDR Text Key335839621
Report Number9610773-2024-00477
Device Sequence Number1
Product Code GCP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K904939
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA4673A
Device Lot Number728065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2016
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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