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 PRIOR TO THE SURGERY, THEY OBSERVED THAT THE OPHTHALMIC GAS REGULATOR HAD AN ISSUE WITH EXTREMELY SLOW GAS RELEASE AND OCCASIONAL NON-RELEASE. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

Additional Manufacturer Narrative

CORRECTION INFORMATION WAS PROVIDED IN SECTION D.4 AND H.4. 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

ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS H.6 AND H.10. 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 NO OTHER COMPLAINTS AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED (B)(4) COMPLAINTS SINCE THE BEGINNING OF 2016. AS OF 03 NOVEMBER 2023 NO SAMPLE HAS BEEN RETURNED. TESTING CANNOT BE PERFORMED. NO SAMPLE WAS RETURNED FOR EVALUATION. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. BASED UPON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED 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).