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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; LAPAROSCOPE
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; LAPAROSCOPE Back to Search Results
Model Number WA53005A
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2023
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's issue was confirmed.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Event Description
The customer reported to olympus, the laparoscope's light guide adapter was loose.The issue was found during preparation for an unspecified diagnostic procedure.There were no reports of patient harm.
 
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Brand Name
TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
Type of Device
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 Key18267258
MDR Text Key329805901
Report Number9610773-2023-03516
Device Sequence Number1
Product Code EWY
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,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWA53005A
Device Lot Number620359
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2023
Was the Report Sent to FDA? No
Date Manufacturer Received11/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2011
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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