BARD-PARKER DISPOSABLE SCALPELS SIZE 11, NON-STERILE

Additional Manufacturer Narrative

THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. A PICTURE WAS PROVIDED, BUT THE COMPLAINT COULD NOT BE CONFIRMED BASED ON WHAT WAS IN THE PICTURE. THE MOST LIKELY ROOT CAUSE IS A MANUFACTURING ERROR, HOWEVER WITHOUT A SAMPLE TO EVALUATE IT CANNOT BE CONFIRMED. USER ERROR MAY ALSO HAVE CAUSED THE BLADE BREAKAGE DUE TO EXCESSIVE FORCE. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

COMPLAINANT ALLEGES "SCALPEL BLADE BROKE OFF IN PATIENT, MOUNT FOR BLADE TO HANDLE BROKE. THE SCALPEL BROKE OFF IN THE PATIENT WHILE CUTTING TISSUES AND HAD TO BE REMOVED."