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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTOSCOPE SHEATH

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OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTOSCOPE SHEATH Back to Search Results
Model Number A22040A
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2023
Event Type  malfunction  
Manufacturer Narrative
The device was returned and evaluated.And the customer¿s allegation was confirmed, due to there being no ceramic tip.In addition, the sealing ring was damaged.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, the root cause of this phenomenon could not be identified.The likely cause of the broken ceramic tip, was wear and tear and/or improper handling by the customer.Investigation activities have been opened to manage actions related to this report and any required mdr reporting.Olympus will continue to monitor the field performance of this device.
 
Event Description
The customer reported to olympus, that when using an inner sheath, for 26 fr.Outer sheath, the ceramic tip was broken.The issue occurred during preparation for use.And the diagnostic procedure (general examination) was completed with a similar device.There was no patient under sedation at the time.No procedural delay.Or no patient harm associated with the event.
 
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Brand Name
INNER SHEATH, FOR 26 FR. OUTER SHEATH
Type of Device
RESECTOSCOPE SHEATH
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key16882679
MDR Text Key314854018
Report Number9610773-2023-01240
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761029339
UDI-Public04042761029339
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K931994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22040A
Device Catalogue NumberA22040A
Device Lot Number169W-0131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2023
Was the Report Sent to FDA? No
Date Manufacturer Received04/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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