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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 Problems Break (1069); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. (b)(4). The returned microknife xl was analyzed, and a visual evaluation noted that the device was in good condition without visual damage. The working length of the device was cut to expose the cutting wire and was observed under magnification and the cutting wire was broken, and the distal tip was blackened. The dimensional and functional evaluation were not performed due to the condition of the device. No other problems with the device were noted. The product analysis revealed that the cutting wire was broken. Upon analysis, it was found that the cutting wire was broken, and blackened including the distal tip, causing the needle unable to extend. Based on the condition of the device, the problem found could have been caused by maximum of voltage rating exceeded while energization or if the cutting wire was not in constant motion. Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure. A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing. A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that a microknife xl was used in the papilla during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2021. During the procedure, the needle of the microknife xl could not extend. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. This event has been deemed a reportable event based on the investigation results: broken cutting wire. Please refer to block h10 for full investigation details.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key11633982
MDR Text Key244415544
Report Number3005099803-2021-01586
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K973826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/04/2022
Device Model NumberM00532810
Device Catalogue Number3281
Device Lot Number0025489578
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2020
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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