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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE PROKNIFE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION ORISE PROKNIFE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00519351
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation results: the returned orise proknife was analyzed, a visual evaluation was performed and the electrode was detached from the device and not returned. No other issues were noted. Based on all available information and the condition of the returned device, it is likely that procedural factors, such as handling and tissue composition, resulted in an electrode detachment. The ifu warns the user to discontinue use if damage is noted. Use of the electrode while damaged can result in the subsequent detachment of the electrode. The investigation concluded the most probable cause 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 per the directions for use (dfu) / product label.
 
Event Description
It was reported to boston scientific corporation that an orise proknife was used in the rectum during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021. During the procedure, the handle was actuated, but the tip did not extend. The procedure was completed with a different device. There were no patient complications reported as a result of this event. Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that electrode was detached from the device.
 
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Brand NameORISE PROKNIFE
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
model farm road cork
cork IRELA ND
EI IRELAND
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12502219
MDR Text Key272487972
Report Number3005099803-2021-04602
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K200404
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 09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00519351
Device Catalogue Number1935
Device Lot Number27159203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Yes
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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