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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE ¿ULTRA¿, 4 MM, 70°, WITH TROCAR TUBE CONNECTOR; RIGID RHINOSCOPE
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OLYMPUS WINTER & IBE GMBH TELESCOPE ¿ULTRA¿, 4 MM, 70°, WITH TROCAR TUBE CONNECTOR; RIGID RHINOSCOPE Back to Search Results
Model Number WA4KA470
Device Problems Crack (1135); Material Integrity Problem (2978); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2024
Event Type  malfunction  
Event Description
It was reported, the rigid rhinoscope had a mechanical damage and noise.The sound black eye piece was cracked.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned and the evaluated and found that the eyepiece funnel was broken.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
TELESCOPE ¿ULTRA¿, 4 MM, 70°, WITH TROCAR TUBE CONNECTOR
Type of Device
RIGID RHINOSCOPE
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 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18797121
MDR Text Key337624237
Report Number9610773-2024-00558
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWA4KA470
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2021
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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