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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 Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2022
Event Type  malfunction  
Manufacturer Narrative
The complainant was able to provide the suspect device lot number however does not populate in gcms; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). The device has been received for analysis; however, the analysis has not yet been completed. Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental emdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a 1. 5mm orise proknife was used in colon during an early malignant tumor submucosal dissection procedure performed on (b)(6) 2022. During the procedure, the inner sheath popped out from the tip immediately after the start of use. The tip detached from the outer sheath. The procedure was completed with another orise proknife. There were no patient complications reported as a result of this event.
 
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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 COPORATION
model farm road cork
cork
EI
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key13715175
MDR Text Key287025551
Report Number3005099803-2022-01286
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,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2022
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 Manufacturer03/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2022
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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