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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00540200
Device Problem Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/26/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). According to the complainant, the suspect device has been end-of-service and is not available for return. If any further relevant information is received, a supplemental medwatch will be filed.

 
Event Description

It was reported to boston scientific corporation that an endostat iii rf generator was used during a colonoscopy with snare polypectomy procedure performed on (b)(6) 2020. According to the complainant, during the procedure and inside the patient, the endostat iii was not heating up properly. Reportedly, the device delivered no energy at all. The procedure was completed with another endostat iii rf generator. There were no patient complications reported as a result of this event. The patient condition following the procedure was reported to be fine.

 
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Brand NameENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR
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)
MEDICAL SCIENTIFIC, INC.
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key9958814
MDR Text Key191562301
Report Number3005099803-2020-01591
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK913881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM00540200
Device Catalogue Number54300
Device LOT Number0000005774
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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