ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS D4 THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS D.9, H.3, H.6 AND H.10 AND CORRECTED INFORMATION PROVIDED IN SECTIONS D.4 AND H.4. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. A NON-CONFORMANCE BASED REVIEW OF THE LOT NUMBER WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT LOT UNDER INVESTIGATION. A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED THREE 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 OF THIS LOT WAS IN GOOD CONDITION AS RECEIVED. THE UNIT WAS TESTED AND FOUND TO HAVE A LOWER THAN REQUIRED FLOW, THE FLOW WAS ABLE TO BE ADJUSTED TO MEET SPECIFICATION. THE DEAD-END PRESSURE WENT ABOVE THE MAXIMUM ALLOWABLE PRESSURE. THE CUSTOMER COMPLAINT IS CONFIRMED. HOW OR WHY THIS REGULATOR BECAME NON-CONFORMING CANNOT BE CONCLUSIVELY DETERMINED, BASED UPON THE INFORMATION PROVIDED AT THIS TIME. THE REPORTED ISSUE HAS BEEN CONFIRMED, AS THE REGULATOR IS FOUND NON-CONFORMING. HOW OR WHY THIS REGULATOR BECAME NON-CONFORMING CANNOT BE CONCLUSIVELY DETERMINED, BASED UPON THE INFORMATION PROVIDED AT THIS TIME. 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).

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTED INFORMATION WAS INCLUDED IN SECTION D.4. 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

A CUSTOMER REPORTED THAT BEFORE THE VITRECTOMY SURGERY, OPHTHALMIC GAS TANK REGULATOR WAS NOT DISPENSING THE GAS. SURGERY WAS COMPLETED BY CHANGING THE GAS TANK. THERE WAS NO IMPACT ON PATIENT.