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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 02/24/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an orise proknife was used in the ascending colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022. About 4 hours into the procedure, the electrode was impossible to deploy. 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 the electrode tip became separated from the electrode body.
 
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). Investigation results: the returned orise proknife was analyzed, a visual evaluation was performed and no damages or additional defects were found. A functional evaluation noted that the thumb slider could easily be adjusted for electrode extension, but no electrode tip extended out. The ceramic tip was removed, and the electrode tip had become separated from the electrode body and was not returned. No other issues were noted. The reported complaint was confirmed. The electrode tip became impossible to deploy because it had become separated from the electrode body. Based on all available information and the condition of the returned device, it is most likely that heat exposure for a long period of time can promote damage in materials such as metal. The dfmea lists electrode burn (hot spot) as a potential cause for electrode assembly detachment. That being said, there are no time restrictions or warnings of the tip falling off after long periods of use. The investigation concluded the most probable root cause is adverse event related to procedure. A device history record (dhr) review was unable to be performed as the lot number is unknown. However, a ship history review was performed to identify the most probable lots, and a dhr review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event. A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
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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
EI
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key14174880
MDR Text Key289895727
Report Number3005099803-2022-02061
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
Type of Report Initial
Report Date 04/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00519351
Device Catalogue Number1935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
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

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