ELECTROSURGICAL PENCIL

Additional Manufacturer Narrative

DURING EVALUATION OF THE RETURNED PENCIL FOUND THE SWITCH PINS WITHIN THE BOVIE WERE SKEWED AND CONNECTED TO INCORRECT INTERNAL WIRES. THE CAUSE OF THE REPORT WAS DUE TO THE MANUFACTURING OPERATOR UNINTENTIONALLY PLACING THE DEVICE IN THE "QUALIFIED" GROUP INSTEAD OF THE "DEFECTIVE" GROUP. A REVIEW OF THE LOGS FOR AUTOMATED ASSEMBLY MACHINE CONFIRMS THE DEVICE WAS IDENTIFIED BUT WAS NOT PRESENT IN THE SCRAP RECORDS. MEGADYNE CONSIDERS THIS A ISOLATED EVENT.

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THIS PRODUCT WAS ORIGINALLY MANUFACTURED TO SPECIFICATIONS. A REVIEW OF COMPLAINT HISTORY WAS CONDUCTED FROM THE LAST TWO YEARS AND INDICATED NO OTHER REPORTS OF THIS SAME ISSUE HAVE BEEN REPORTED WHICH INDICATED A MALFUNCTION. ALSO SEARCH OF COMPLAINT HISTORY FOR REPORTED LOT NUMBER RESULTED IN NO OTHER COMPLAINTS ISSUED. DURING INITIAL EVALUATION, THE DEVICE WAS PLUGGED INTO A ESU AND CONTINUOUS ELECTRICAL CONNECTION WAS OBSERVED. THE DEVICE HAS BEEN FORWARDED TO MEGADYNE'S SUPPLIER AND INVESTIGATION IS ON GOING TO DETERMINE CAUSE.

Description of Event or Problem

BOVIE PENCIL WAS PLUGGED IN AND AUTOMATICALLY TURNED ON. UNPLUGGED AND BUTTON WAS NOT PRESSED, PLUGGED IN AGAIN AND PENCIL AUTOMATICALLY TURNED ON AGAIN. BOVIE WAS REPLACED WITH A DIFFERENT BOVIE WITH NO ISSUES. NO PATIENT INJURY.