ISPAN GAS TANK REGULATOR

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED SCHEDULED PROCEDURE WAS CATARACT AND VITRECTOMY COMBINATION.

Additional Manufacturer Narrative

THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. A NON-CONFORMANCE BASED REVIEW OF THE SERIAL 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 SERIAL NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT SERIAL UNDER INVESTIGATION. CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED SIX OTHER COMPLAINTS AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 25 COMPLAINTS SINCE THE BEGINNING OF 2016. THE SAMPLE WAS NOT RETURNED. BASED UPON THE INFORMATION PROVIDED, A ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. BASED UPON THE INFORMATION PROVIDED, A ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. 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

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 OPHTHALMIC GAS TANK VALVE NOT MEASURING THE VOLUME CONTAINED AND NOT RELEASING THE GAS FOR USE, EVEN WITH A FULL TORPEDO. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.