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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN UNKNOWN

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UNKNOWN UNKNOWN Back to Search Results
Model Number UNKNOWN
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The subject device has not been received for evaluation. The cause of the issue cannot be determined at this time. If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that the patient post an endobronchial ultrasound bronchoscopy (ebus) coughed up an ebus needle. According to the report, the ebus procedure done on the patient was not performed at the facility where the patient was reported to have coughed up the ebus needle. No other information provided regarding the event and no patient harm or injury reported due to the event.
 
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Brand NameUNKNOWN
Type of DeviceUNKNOWN
Manufacturer (Section D)
UNKNOWN
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9889027
MDR Text Key222559249
Report Number8010047-2020-01875
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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