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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 M00519361
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an orise proknife was used during an unknown procedure performed on (b)(6) 2022.During the procedure, the orise electrode was damaged (with separation).It was not reported if the device was inside the body or in the sheath of the device.The procedure was completed with another orise proknife.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an orise proknife was used during an unknown procedure performed on (b)(6) 2022.During the procedure, the orise electrode was damaged (with separation).It was not reported if the device was inside the body or in the sheath of the device.The procedure was completed with another orise proknife.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0501 captures the reportable event of the electrode tip detachment.Block h10: investigation results the returned orise proknife was analyzed, a visual evaluation noted that no damages or additional defects were found.A functional evaluation noted that the electrode did not extend from the tip.The distal tip was inspected; the tip of the electrode was observed to be detached.The ceramic tip was removed from the device to observe the location of electrode detachment.No other issues were noted.The reported complaint was confirmed.Based on all available information and the condition of the returned device, it is likely that procedural factors, such as the length of time used, power settings required, handling technique, and/or tissue composition resulted in the electrode damage, and subsequent use of the electrode resulted in the detachment.It indicates that the event occurred due to the nature of the procedure, and the device had no influence on the event.The investigation concluded the most probable root cause is adverse event related to procedure.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 for distribution.A labelling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.There were no issues found with the translation, wording, or graphics in the dfu.
 
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Brand Name
ORISE PROKNIFE
Type of Device
UNIT, 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
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key14005161
MDR Text Key288662508
Report Number3005099803-2022-01520
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 Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00519361
Device Catalogue Number1936
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
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
Patient Sequence Number1
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