ISPAN GAS TANK REGULATOR

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

A CUSTOMER REPORTED THAT BEFORE A CATARACT-VITRECTOMY PROCEDURE AN OPHTHALMIC REGULATOR WAS NOT FUNCTIONING PROPERLY AND WOULD NOT RELEASE GAS. PROCEDURE WAS COMPLETED BY REPLACING THE REGULATOR. THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

CORRECTED INFORMATION PROVIDED IN SECTIONS D.2A, D.2B AND G.4. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS D.9, H.3, H.6 AND H.10 THE COMPANY REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED EVENT. INITIALLY THERE WAS NO FLOW OF GAS. THE PISTON WAS CHECKED AND FOUND TO HAVE TAKEN A SEAT, AFTER FREEING THE UNIT RELEASED GAS BUT WAS HIGH OUT OF SPECIFICATION. THE UNIT WAS ABLE TO BE ADJUSTED TO MEET FLOW SPECIFICATIONS. THE DEAD-END PRESSURE AT 100 PSI ALSO FAILED AND THE PRESSURE CONTINUED TO CREEP UPWARD. NO FURTHER TESTING WAS PERFORMED. THE CUSTOMER COMPLAINT IS CONFIRMED. A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT, SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 26 COMPLAINTS SINCE THE BEGINNING OF 2016. ONE REGULATOR FROM THIS LOT, WAS TESTED WAS FOUND IN GOOD CONDITION. THE REGULATOR WAS PUT THROUGH FINAL TEST AND INSPECTION. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT IS A FAULTY UNIT. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).