Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR; 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 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00540200R0
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an endostat iii rf generator was to be used in an unknown procedure on (b)(6) 2019.According to the complainant, during the procedure, the generator no longer catheterized and they were not getting any error messages.Different catheters were tried.The procedure was completed with another endostat iii rf generator.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that an endostat iii rf generator was to be used in an unknown procedure on (b)(6) 2019.According to the complainant, during the procedure, the generator no longer catheterized and they were not getting any error messages.Different catheters were tried.The procedure was completed with another endostat iii rf generator.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on november 13, 2019.According to the complainant, the console failed to power up.There were no other issues with the device.Colonoscopy was the procedure performed on (b)(6) 2019.The patient's condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
Problem codes 1198 captures the reportable event of failure to power up with patient involvement.According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.(initial reporter first name) have been updated with the additional information received on november 13, 2019.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9309418
MDR Text Key189705251
Report Number3005099803-2019-05497
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K913881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00540200R0
Device Catalogue Number54455
Device Lot Number0000005032
Was Device Available for Evaluation? No
Date Manufacturer Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-