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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC BIPOLAR, HEMOSTASIS CATHETER

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BOSTON SCIENTIFIC BOSTON SCIENTIFIC BIPOLAR, HEMOSTASIS CATHETER Back to Search Results
Model Number MOO560150
Device Problems Malfunction (2409); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Code Available (3191)
Event Date 06/15/2020
Event Type  Injury  
Event Description
Pt undergoing an egd and the 3 lesions could not be treated as the gold probe malfunctioned. Procedure was cancelled and repeat endoscopy rescheduled.
 
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Brand NameBOSTON SCIENTIFIC
Type of DeviceBIPOLAR, HEMOSTASIS CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC
one boston scientific place
natick MA 01760
MDR Report Key10188761
MDR Text Key196557569
Report Number10188761
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMOO560150
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2020
Distributor Facility Aware Date06/15/2020
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer06/18/2020
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/19/2020 Patient Sequence Number: 1
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