FINESSE FLEX LOOP DSP

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS D.9, H.3, H.6 AND H.11. THE RETURNED INSTRUMENT WAS RECEIVED AT THE MANUFACTURING SITE IN ITS INNER AND OUTER BLISTER, COVERED WITH THE TYVEK LID FOIL SHOWING THE LOT INFORMATION. THE PRODUCT WAS RETURNED WITH THE LOOP IN RETRACTED STATE AND SHOWS NO MACROSCOPIC SIGNS OF DAMAGE BUT A FEW SIGNS OF SURGERY RESIDUES. FUNCTIONAL TESTING SHOWED THAT THE RETRACTION AND PROTRACTION MECHANISM WAS IN WORKING CONDITION. THE INSTRUMENT WAS VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE WITH VARIOUS MAGNIFICATIONS, HOWEVER, WHEN THE LOOP WAS EXTENDED, IT WAS NOTICED THAT IT HAD BROKEN. AS THE BLISTER WAS OPENED BY THE CUSTOMER, THE PRODUCT WAS HANDLED. THEREFORE, THE POINT IN TIME WHEN THE DEFECT ON THE LOOP OCCURRED CAN NO LONGER BE DETERMINED, NOR CAN THE STRAIN PUT ON THE DEVICE BE RECONSTRUCTED. THE CUSTOMER¿S COMPLAINT IS CONFIRMED, BUT A ROOT CAUSE FOR THE BREAKAGE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. A NON-CONFORMANCE BASED REVIEW OF THE LOT NUMBER WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. NO ROOT CAUSE FOR THE CUSTOMER'S REPORTED EVENT COULD BE DETERMINED, SINCE THE SITUATION THAT LEAD TO THE INSTRUMENT FAILURE CANNOT BE RECONSTRUCTED. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL MANUFACTURE PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. THE COMPLAINT DATA WILL CONTINUE TO BE MONITORED FOR EVIDENCE OF ADVERSE TRENDING AND FURTHER ACTION WILL BE TAKEN, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED THAT A DURING VITREORETINAL SURGERY AN OPHTHALMIC SCRAPER LOOP WAS BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING NEW DEVICE. THERE WAS NO PATIENT IMPACT.