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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); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The returned microknife xl was analyzed, and a visual evaluation noted that the cutting wire was broken. The device was observed under magnification and the cutting wire was broken, blackened, and kinked/bent. These findings were consistent upon destructive analysis of the distal components after the device was cut. A functional evaluation was not performed due to the device condition. No other problems with the device were noted. The product analysis revealed that the cutting wire was broken, blackened, and kinked/bent. The cutting wire being blackened indicates that the device was energized. Based on the condition of the device, the problem found could have been caused if the device was energized prior to performing sphincterotomy which can compromise the cutting wire's integrity and cause premature cutting wire fatigue. The problem could have also been generated if the device was activated in an incorrect position or if in contact with other medical device. 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.
 
Event Description
It was reported to boston scientific corporation that a microknife xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021. During the procedure, "the needle did not externalize" when they pulled the device. It was reported that the device was exchanged with another device. It was unknown what device was used to complete the procedure. There were no reported patient complications as a result of this event. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts. This event has been deemed a reportable event based on the investigation results: the cutting wire was broken. Please refer to 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 Key12627598
MDR Text Key278637976
Report Number3005099803-2021-05177
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeBR
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 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00532810
Device Catalogue Number3281
Device Lot Number0026067650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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