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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); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2021
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 distal section of the needle was broken and blackened. A functional evaluation performed by the actuating the handle and the wire moved forward and backward; however, the needle did not extend because the needle was broken. No other problems with the device were noted. The product analysis revealed that the needle (cutting wire) was broken and blackened. The broken section was not returned. The cutting wire being blackened indicates that the device was energized. These conditions could have been caused due to procedural factors such as the technique used, the patient anatomy, interaction with the scope or additional devices, also if it was exceeded the maximum of voltage or if the cutting wire was not in constant motion as per the instructions for use (ifu) states. 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 in a manner inconsistent with the instructions for use (ifu). Additional information states that the device was used to cut a pseudocyst located in the stomach; however, according to the instructions for use (ifu), the sphincterotome is indicated for use in the selective cannulation of the common bile ducts (cbd) and the transendoscopic sphincterotomy of the papilla of vater and/or the sphincter of oddi.
 
Event Description
It was reported to boston scientific corporation that a microknife xl was used during a pseudocyst drainage and double pigtail placement procedure in the stomach performed on (b)(6) 2021. During the procedure, the pseudocyst was punctured, cut, and removed using the microknife xl. When they tried to cut again, the needle did not come out of the sheath. It was reported that there was no visible damage noted on the device. The device was removed and 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. Note: it was reported that the microknife xl was used to cut a pseudocyst located in the stomach. However, according to the instructions for use (ifu), the sphincterotome is indicated for use in the selective cannulation of the common bile ducts (cbd) and the transendoscopic sphincterotomy of the papilla of vater and/or the sphincter of oddi, and the reported anatomy location is not described in the indications for use. This event has been deemed a reportable event based on the investigation results: the needle (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 Key12911961
MDR Text Key283623042
Report Number3005099803-2021-06130
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUY
PMA/PMN Number
K973826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00532810
Device Catalogue Number3281
Device Lot Number0027345849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2021
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2021
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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