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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID OPTICAL LAPAROSCOPE
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID OPTICAL LAPAROSCOPE Back to Search Results
Model Number WA53000A
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was observed that during the device inspection, the telescope, 10 mm, 0°, hd, quick lock, autoclavable lens of the distal end was damaged.There were no reports of patient harm.
 
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Brand Name
TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE
Type of Device
RIGID OPTICAL LAPAROSCOPE
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 Key18940647
MDR Text Key338998705
Report Number9610773-2024-00787
Device Sequence Number1
Product Code EWY
UDI-Device Identifier04042761052757
UDI-Public04042761052757
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K950076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberWA53000A
Device Lot Number579059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/15/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
OTV-S190
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