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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 Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. Approximated based on the date the manufacturer became aware of the event. (b)(4) captures the reportable investigation results of wire broken. The returned microknife xl was analyzed, and a visual evaluation noted that the wire in the handle was broken and the hypotube transition was kinked. These findings were consistent with the findings when the device was observed under magnification. An x-ray inspection was performed, and the wire was kinked inside the handle. No other problems with the device were noted. The product analysis revealed that the wire in the handle was broken. It was also found that the wire inside the handle was kinked which could have induced the wire to break inside the handle. These conditions could have been generated due to the technique used during the removal of the device from the pouch or during the preparation. 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 intended to be used in the common bile duct in an endoscopic retrograde cholangiopancreatography (ercp) procedure. The exact procedure date was unknown. During preparation, it was noticed that the wire would 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: the wire in the handle was broken.
 
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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 Key14115884
MDR Text Key289314994
Report Number3005099803-2022-01999
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K973826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00532810
Device Catalogue Number3281
Device Lot Number0028483216
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2021
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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