D
Patient 1
(B)(4) SALES REPRESENTATIVES WAS NOTIFIED BY FACILITY THAT DURING A BIPOLAR TURBT PROCEDURE TWO NURSES WERE SHOCKED WHEN THEY GRABBED THE BIZ MONITOR DEVICE WHILE REMOVING IT FROM THE PATIENT. NO INJURY TO PATIENT WAS REPORTED. TWO SEPARATE MDRS WILL BE SUBMITTED, ONE FOR EACH NURSE: MDR 1418479-2017-00018, NURSE #1, MDR 1418479-2017-00019, NURSE #2. USER FACILITY WAS CONTACTED IN AN EFFORT TO GATHER ADDITIONAL/MISSING MEDWATCH INFORMATION, NO RESPONSE AS OF 08/22/17. MANUFACTURER / DEVICE RETURNED FOR INVESTIGATION: (B)(4) WORKING ELEMENT (ID #8680.224 LT #1324186), (B)(4) ELECTRODE (ID #4622.1313 LT #51007450), (B)(4) BIPOLAR CABLE (ID #8108.232 LT #07/14), (B)(4) UNIPOLAR CABLE (ID #815.033 LOT #128/180). ADDITIONAL DEVICES USED DURING PROCEDURE: (B)(4) GENERATOR (ID #UNKNOWN), BIZ MONITOR (ID #UNKNOWN). MANUFACTURED DATE: 12-OCT-2016, PURCHASE DATE: (B)(6) 2017, SERVICE DATE: N/A. (B)(4) RECEIVED ACTUAL DEVICE FROM USER FACILITY ON 03-AUG-2017. A VISUAL INSPECTION OF DEVICE FOUND SHAFT WAS BENT. NO PROBLEMS FOUND WHEN FUNCTIONAL TESTING WAS PERFORMED ON DEVICE. (B)(4) COULD NOT REPLICATE EVENT WITH THE DEVICES RETURNED FOR INVESTIGATION. NONE OF THE RETURNED DEVICES CONTAINED DAMAGE OR DEFECTS THAT WOULD HAVE CAUSED NURSE TO BE SHOCKED. ROOT CAUSE OF EVENT IS UNKNOWN. ONE SIMILAR EVENT RESULTING IN AN MDR HAS OCCURRED ON THIS DEVICE IN THE LAST THREE YEARS (MDR 1418479-2015-00034). (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES ADDITIONAL INFORMATION, FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.