• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 12/09/2021
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an orise proknife was used during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021. During the procedure, the electrode did not move at all and it may have become disconnected. The procedure was completed with another of the same 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 investigation results which revealed that the electrode was detached.
 
Manufacturer Narrative
Initial reporter address 1: (b)(6). Medical device problem code: (b)(4). Investigation results the returned orise proknife was analyzed, a visual evaluation was performed and the electrode was not present at the tip of the device. 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 the length of time used, power settings required, handling technique, and/or tissue composition resulted in the electrode damage. Subsequent use of the electrode may have resulted in the detachment. The investigation concluded that the most probable root cause is adverse event related to procedure, which indicates that the event occurred due to the nature of the procedure, and the device had no influence on the event. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13625114
MDR Text Key288106279
Report Number3005099803-2022-00672
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 02/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2022
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 Manufacturer01/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2022
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

-
-