Description of Event or Problem · 1
ON (B)(6) 2014 FACILITY CONTACTED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) INDICATING THEY WOULD LIKE TO SEND IN THEIR WORKING ELEMENTS FOR "EVALUATION." IN AN E-MAIL, DATED (B)(6) 2014, DISCUSSING WORKING ELEMENTS IN GENERAL, FACILITY MENTIONED AN INCIDENT WHERE A SPARK OCCURRED ON (B)(6) 2014. IT APPEARS THE INSTRUMENT IN QUESTION WAS ONE OF THE WORKING ELEMENTS SENT IN FOR EVALUATION. FACILITY INDICATED NO INJURY TO PATIENT OR STAFF OCCURRED. IN ADDITION, NO DELAY IN A PROCEDURE PLACING A PATIENT AT RISK WAS REPORTED. A FEW PARTS ON DEVICE WERE REPLACED DUE TO BEING LOOSE AND/OR WORN OUT. PURCHASE DATE: 10/2011, NO RECORD OF ANY ROUTINE MAINTENANCE OR REPAIRS. AN INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED ON (B)(4) 2014. A FEW PARTS ON DEVICE WERE REPLACED DUE TO BEING LOOSE AND/OR WORN OUT. DEVICE HISTORY: PURCHASED 10/2011, NO RECORD OF ANY ROUTINE MAINTENANCE OR REPAIRS. IF MOISTURE OR LIQUID WERE TO GET IN LOCK HOUSING, A SPARK MAY OCCUR (I.E. DEVICE NOT COMPLETELY DRIED AFTER REPROCESSING OR FROM SALINE DURING USE DUE TO WORN O-RING). LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE., I.E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFORMATION, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.