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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); Use of Device Problem (1670); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Visual examination of the returned device revealed that the needle was found broken and the tip of the device damage and blackened. According to the product analysis, the cutting wire of the device product needle was found broken and the tip damage, so it is most likely that a peak of voltage could caused the failure noted if the guidewire was inside the device during cautery procedure and the guidewire used was not the recommended by directions for use (dfu). Therefore, the most probable cause of this complaint is failure to follow instructions since problems traced to the user not following the manufacturer's instructions. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
 
Event Description
It was reported to boston scientific corporation that a microknife xl was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) with pancreatic sphincterotome procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the boston scientific microknife xl was used along with a cook medical roadrunner guidewire connected to a bovi during the sphincterotomy, when the physician initiated the bovi, there was a spark at the surgical site and a small segment of guidewire was broken and retained inside the dorsal pancreatic duct. The procedure was completed with a different 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.
 
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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 DE COSTA RICA S.R.L.
2546 calle primera
alajuela
CS
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key9407169
MDR Text Key189754719
Report Number3005099803-2019-05883
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 12/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2020
Device Model NumberM00532810
Device Catalogue Number3281
Device Lot Number0022945338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2018
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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