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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); Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The returned microknife was analyzed, and a visual evaluation noted that the blue tip was melted and blackened. Also, the needle during extension was blackened and broken. A functional evaluation noted that a test guidewire advanced to the end of the device as intended. No other visual damage was noted. The reported event was confirmed. According to the product analysis, the needle of the returned device was broken, the working length and the needle were blackened, and the working length melted. The failure found could had been generated if the handle was not fully retracted during advancing inside the scope or if there was contact between the scope and the needle while electrical current was applied. 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 directions for use (dfu)/product label.
 
Event Description
It was reported to boston scientific corporation that a microknife xl was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the cutting wire was unable to extend out of the sheath. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable. This event has been deemed reportable based on the investigation results: cutting wire broke.
 
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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 Key10487900
MDR Text Key205507263
Report Number3005099803-2020-03665
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K973826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/04/2021
Device Model NumberM00532810
Device Catalogue Number3281
Device Lot Number0024381731
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2019
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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