ISPAN GAS TANK REGULATOR

Description of Event or Problem

A CUSTOMER REPORTED THAT AN OPHTHALMIC REGULATOR WAS SLOW TO DISPENSE GAS BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED WITH THE SAME PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

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).

Additional Manufacturer Narrative

A REGULATOR WAS RETURNED ON THIS INVESTIGATION. A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED. A CHECK OF THE COMPLAINT RECORDS SHOWED ONE OTHER COMPLAINT AGAINST LOT. THEREFORE, THERE ARE POTENTIAL CONTRIBUTING FACTOR(S) IDENTIFIED. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT WAS PERFORMED. THESE COMPLAINTS WERE DETERMINED TO NOT BE RELEVANT TO THIS INVESTIGATION. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. TWO REGULATORS WERE RECEIVED IN GOOD CONDITION AND TESTED FOR FLOW. ONE REGULATOR HAD NO FLOW AND COULD NOT BE ADJUSTED. THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE CAN BE ATTRIBUTED TO FAULTY REGULATORS. 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

CORRECTED INFORMATION PROVIDED IN SECTIONS D.4. AND H.11. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).