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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID OPTICAL LAPAROSCOPE
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID OPTICAL LAPAROSCOPE Back to Search Results
Model Number WA53005A
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2024
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 reported the rigid optical laparoscope light guide bundle was showing concealed breaks.There was no procedural delay and the patient was not under anesthesia.There were no reports of patient harm or injury.
 
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Brand Name
TELESCOPE, 10 MM, 30°, 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 Key18969263
MDR Text Key338809229
Report Number9610773-2024-00838
Device Sequence Number1
Product Code EWY
UDI-Device Identifier04042761052764
UDI-Public04042761052764
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,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWA53005A
Device Lot Number556718
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/10/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/09/2008
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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