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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; LITHOTRIPTOR, BILIARY MECHANICAL

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OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; LITHOTRIPTOR, BILIARY MECHANICAL Back to Search Results
Model Number A22040A
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
Event Type  Injury  
Event Description
The customer reported to olympus stating that the ceramic tip broke off inside the patient during an unknown therapeutic procedure.The doctor was able to retrieve all the pieces.Details of the patient's current condition, procedural details and outcome of the procedure were requested but not available at the time of the report.
 
Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2023-00395.The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
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Brand Name
INNER SHEATH, FOR 26 FR. OUTER SHEATH
Type of Device
LITHOTRIPTOR, BILIARY MECHANICAL
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 Key18307052
MDR Text Key330228672
Report Number9610773-2023-03594
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761029339
UDI-Public04042761029339
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K931994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA22040A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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