MOXY

Additional Manufacturer Narrative

RICHARD WOLF GMBH(RWGMBH) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWGMBH RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION(RWMIC) SUBMITTING REPORT ON BEHALF OF RWGMBH REPORT ON BEHALF OF RWGMBH.

Description of Event or Problem

RICHARD WOLF GMBH REPORTS THAT: THE CUSTOMER SENT US THE LASER WORKING INSERT TYPE 8632.284. IN SPITE OF REPEATED REQUESTS, THE ATTACHMENT FOR CYSTOSCOPE TYPE 8650264 WAS NOT SENT TO US, SO THAT ONLY THE LASER WORKING INSERT TYPE 8632.284 COULD BE EXAMINED. THE PRESENT LASER WORKING INSERT TYPE 8632.284 ORIGINATES FROM THE BATCH: 1249546 AND WAS BOOKED TO THE NEW STOCK ON JUNE 10, 2014 WITH AN ORDER SIZE OF 15 PIECES. THE CHECK OF THE FLOW CHART DID NOT SHOW ANY ANOMALIES. THE DELIVERY TO THE CUSTOMER TOOK PLACE ON 05.11.2014. THE INSPECTION OF THE LASER WORK INSERT IN THE SPECIALIST DEPARTMENT DID NOT REVEAL ANY FUNCTIONAL DEFECT. HOWEVER, THE LASER WORK INSERT HAS CLEAR SIGNS OF USE DUE TO ITS AGE AND USE AND IS THERMALLY ATTACKED BY THE USE OF THE LASER. THE CAUSE CAN BE TRACED BACK TO USER ERROR. WITH REGARD TO SEVERAL NUMBER OF PIECES, WORLDWIDE DELIVERED WORKING INSERTS AND NO COMPARABLE COMPLAINT CASE OF THIS TYPE, A PRODUCT PROBLEM OR A MANUFACTURING PRODUCT PROBLEM OR A MANUFACTURING DEFECT CAN BE RULED OUT. THIS IS FURTHERMORE CONFIRMED BY THE FACT THAT THE PRESENT APPROACH HAS ALREADY BEEN DELIVERED FOR 7 YEARS. THUS, NO "EARLY FAILURE" DUE TO A PRODUCT DEFECT IS EVIDENT. IN GENERAL, THE USER IS INFORMED IN THE ASSOCIATED GA-D323 OPERATING INSTRUCTIONS IN CHAPTER 8 THAT THE USER MUST CARRY OUT A VISUAL AND FUNCTIONAL CHECK BEFORE AND VISUAL AND FUNCTIONAL CHECK BEFORE AND AFTER EACH USE. PRODUCTS WHICH ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS, DO NOT USE THEM AGAIN SEND DAMAGED PRODUCTS WITH THE LOOSE PARTS FOR REPAIR. POSSIBLE FUNCTIONAL IMPAIRMENTS OF THE ABOVE TYPE CAN EASILY BE DETECTED BY THE USER IF THESE INSTRUCTIONS ARE FOLLOWED. IN THE B6-2 RISK ASSESSMENT, HANDLING-RELATED, AS WELL AS MANUFACTURING-RELATED AND DESIGN-RELATED RISKS (INSTRUMENT EXCHANGE, OPERATING ROOM DELAYS) ON THE PRODUCT WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE WERE CONSIDERED AND EVALUATED AND ASSESSED AS AN ACCEPTABLE RISK. IN THE PERIOD UNDER REVIEW, THERE WERE NO COMPLAINTS OR CLAIMS WITH REGARD TO THE NUMEROUS DELIVERIES OF THIS TYPE NO COMPLAINTS OR INCIDENTS HAVE BEEN REGISTERED. AS NO NEW RISKS HAVE ARISEN FROM THE INVESTIGATION OF THE CURRENT COMPLAINT CASE, THE RISK. SINCE NO NEW RISKS HAVE ARISEN FROM THE INVESTIGATION OF THE CURRENT COMPLAINT CASE, THE RISK ASSESSMENT REMAINS VALID IN VIEW OF THE FACTS DESCRIBED. FROM THE FINDINGS OF THE INVESTIGATION, IT IS POSSIBLE TO DRAW UP A SYSTEMATIC AND PRODUCTION TECHNOLOGY, A SYSTEMATIC DEFECT CAN BE RULED OUT. BASED ON THE CONVINCING STATISTICS, THE FACTS CANNOT BE ATTRIBUTED TO A PRODUCT PROBLEM. BASED ON THE INDIVIDUAL CASE WITH THIS TYPE AND THE ABOVE FINDINGS, AND SINCE, ACCORDING TO OUR EXPERIENCE, THERE ARE NO INDICATIONS OF A NO SIGNS OF SYSTEMATIC DEFECTS CAN BE DEDUCED FROM OUR EXPERIENCE, NO MEASURES WILL BE TAKEN.

Additional Manufacturer Narrative

RICHARD WOLF MIC IS SUBMITTING THIS MDR ON BEHALF OF RW (B)(4). INSTRUMENT HAS NOT YET BEEN SENT FOR EXAMINATION. AS SOON AS WE GET NEW FINDINGS WE WILL SEND A FOLLOW-UP REPORT.

Description of Event or Problem

IT WAS REPORTED TO RICHARD WOLF (B)(4), THAT ON (B)(6) 2021 : MOXY FIBER LASER 180 W REF 0010-2400 LOT 24655515 OF 2021-10-24 GETS STUCK IN THE 8632284 LASER WORKING INSERT 12/30 BEGINNING OF SURGERY AND BREAKS IN PATIENT'S BLADDER. CHANGE FIBER TO COMPLETE SURGERY. CONSEQUENCES FOR THE PATIENT, USER OR OTHER PERSON: GREAT DIFFICULTY OF SURGICAL PROCEDURE SURGICAL TIME INCREASED TO 2 HOURS INSTEAD OF 1 H.FIBERS FROM RICHARD WOLF (B)(4) AND BOSTON ARE INVOLVED.