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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); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2021
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)(6). (b)(4). The returned microknife xl was analyzed, and a visual evaluation noted that the cutting wire was broken at the handle section. The handle did not have any visual damage. The device was observed under magnification and the cutting wire was broken and bent at the handle section and the cut of the cutting wire was not smooth. It was also observed evidence of bending forces at the broken area. No other problems with the device were noted. The product analysis revealed that the cutting wire was broken and bent at the handle section. Based on the condition of the device and the information that the problem occurred during procedure, it is most likely that procedural factors encountered during procedure could have affected the device performance and its integrity. The broken section of the wire was inspected under magnification and it was observed evidence of bending forces, it is most likely that the wire was bent due to handling and manipulation of the device during its use, once the wire is bent, continued attempts to actuate the handle can result in wire breakage. Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event 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 esophagogastroduodenoscopy (egd) and endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021. During the procedure, when the microknife xl was opened, it was noticed that the handle was damaged and the needle would not extend. It was reported that the procedure was completed; however, it is unknown what device was used to complete the procedure. 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 ok. This event has been deemed a reportable event based on the investigation results: the cutting wire 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 Key11882091
MDR Text Key256281426
Report Number3005099803-2021-02316
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/06/2022
Device Model NumberM00532810
Device Catalogue Number3281
Device Lot Number0025675160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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