HARMONIC SCALPELS/SHEARS

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE TISSUE PAD FELL OFF INTO PATIENT. IT APPEARED ALMOST LIKE IT MELTED. THE TISSUE PAD WAS RETRIEVED FROM THE PATIENT WITHOUT ANY ADVERSE OUTCOMES. ONCE THE FRAGMENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO DIFFICULTY NOTICED BEFORE THE BREAK, NOR A SPECIFIC PROCEDURAL OR PATIENT CIRCUMSTANCE THAT CONTRIBUTED TO THE BREAK.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE TISSUE PAD FELL OFF INTO PATIENT. THE DEVICE WAS RETURNED ON 5-AUG-2021 FOR ANALYSIS. THE DEVICE WAS RETURNED INSIDE ITS CLAYBOARD BOX, WITHOUT THE TRAYFORM OR ANY OTHER PROTECTIVE MATERIAL. NO OTHER ORIGINAL PACKAGING HAD BEEN RETURNED. THE RETURNED DEVICE WAS RECEIVED WITH OBSERVED BIOLOGICAL CONTAMINANTS ON THE HANDLE, SHAFT AND TIP OF THE DEVICE, ESCHAR ON THE METAL ROD, ALSO, A MELTED AND DETACHED TISSUE PAD. THE TISSUE PAD IS MELTED DOWN ITS CENTER WITH THE BASE STILL SEATED WITHIN THE JAW¿S GROOVE WITH THE EDGES APPEARING SMOOTH AND MELTED. THE OBSERVATIONS ARE INDICATIVE OF CONTINUOUS DEVICE ACTIVATION WITHOUT TISSUE PRESENT BETWEEN THE TISSUE PAD AND THE METAL ROD. THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE WAS THEN ATTACHED TO AN ETHICON HARMONIC HP054 HAND PIECE AND WAS SECURED WITH A TORQUE WRENCH. IT WAS PLUGGED INTO GENERATOR G11 (GEN11 - SOFTWARE VERSION 2016-1.1) TO VERIFY FUNCTIONALITY. THE GENERATOR NOTED IT WAS IDENTIFYING THE DEVICE, THEN PROCEEDED TO THE "SYSTEM READY" SCREEN. THIS INDICATES THE DEVICE IS OPERATIONAL, HAS REMAINING SEALING ACTIVITIES AND HAS NOT REACHED ITS END-OF-LIFE FUNCTIONALITY. PER THE FAILURE MODE AND EFFECTS ANALYSIS (FMEA) FOR HARMONIC ACE WITH ATT, POSSIBLE CAUSES FOR THE "PAD MISSING OR FRAGMENT FALLS OFF" IS "ACTIVATION OF DEVICE WITHOUT TISSUE BETWEEN THE BLADE AND THE PAD, USER ERROR AND PHYSICIAN MISUSE.¿ PER THE INSTRUCTIONS FOR USE REPROCESSED HARMONIC ACE® +7 SHEARS WITH AH, ¿BLOOD AND TISSUE BUILDUP BETWEEN THE BLADE AND SHAFT MAY RESULT IN ABNORMALLY HIGH TEMPERATURES AT THE DISTAL END OF THE SHAFT.¿ IT ALSO NOTES ¿CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. CLAMPING THE TISSUE PAD AGAINST THE ACTIVE BLADE WITHOUT TISSUE ON THE FULL LENGTH OF THE BLADE WILL RESULT IN HIGHER BLADE, CLAMP ARM AND DISTAL SHAFT TEMPERATURES AND CAN RESULT IN POSSIBLE DAMAGE TO THE INSTRUMENT." AND, "KEEP THE CLAMP ARM OPEN WHEN BACKCUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD AND INCREASED BLADE, CLAMP ARM AND DISTAL SHAFT TEMPERATURES.¿ IT NOTES IN THE OPERATION OF THE DEVICE ¿FOR OPTIMAL PERFORMANCE AND TO AVOID TISSUE STICKING, CLEAN THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL END OF THE SHAFT THROUGHOUT THE PROCEDURE BY ACTIVATING THE INSTRUMENT TIP IN SALINE.¿ WHILE THE OBSERVED EVIDENCE IS INDICATIVE OF THE DEVICE BEING ACTUATED WITHIN THE OPERATIVE FIELD WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD, AND THE FAILURE IS REPORTED TO HAVE OCCURRED INTRA-OP (WITH NO CLEAR INDICATIONS THAT THE WARNINGS AND INSTRUCTIONS WERE FOLLOWED), NO CONCLUSION AS TO THE CAUSE FOR THE REPORTED ISSUE IS DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 2156085 IS REVIEWED, AND THE DEVICE IS SHOWN TO HAVE PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO BEING DISTRIBUTED TO THE CUSTOMER. IN ADDITION, A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AND THERE WERE NO IDENTIFIED NONCONFORMANCES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).