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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC, RADIAL JAW 4; BIOPSY FORCEPS
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BOSTON SCIENTIFIC BOSTON SCIENTIFIC, RADIAL JAW 4; BIOPSY FORCEPS Back to Search Results
Model Number RADIAL JAW 4
Device Problems Break (1069); Cable break (1076); Unintended System Motion (1430); Scratched Material (3020); Noise, Audible (3273)
Patient Problem Pneumothorax (2012)
Event Date 03/02/2016
Event Type  Injury  
Event Description
While performing forceps biopsy a noise was heard, instrument removed and inspected, revealing broken biting mechanism.Wires holding jaws together (normal on bottom) broke, allowing the jaws to pivot (top forceps), increasing the size approximately 3-4x and exposing sharp edges.
 
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Brand Name
BOSTON SCIENTIFIC, RADIAL JAW 4
Type of Device
BIOPSY FORCEPS
Manufacturer (Section D)
BOSTON SCIENTIFIC
300 boston scientific way
malborough MA 01752 1234
MDR Report Key5573049
MDR Text Key42614071
Report Number5573049
Device Sequence Number1
Product Code BWH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/29/2016,03/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/27/2018
Device Model NumberRADIAL JAW 4
Device Catalogue NumberM00515180
Device Lot Number18546277
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2016
Distributor Facility Aware Date03/02/2016
Event Location Other
Date Report to Manufacturer04/01/2016
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age83 YR
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