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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MICROKNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION MICROKNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00532810
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/02/2021
Event Type  malfunction  
Event Description
Patient had bronchoscopy procedure performed by doctor. During the procedure, doctor was utilizing a boston scientific microneedle. The needle-knife portion broke off during the procedure into the patient's lung. Doctor was able to retrieve the piece from the lung.
 
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Brand NameMICROKNIFE XL
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key13522918
MDR Text Key285543121
Report Number13522918
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/08/2021,12/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00532810
Device Catalogue NumberM00532810
Device Lot Number27190664
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/08/2021
Event Location Hospital
Date Report to Manufacturer02/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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