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 PHYSICIAN REPORTED THAT AN OPHTHALMIC REGULATOR WAS NOT ABLE TO USE AS IT WOULD NOT RELEASE GAS WHEN THE KNOB WAS PLACED IN THE OPEN POSITION. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAS TO MANUALLY DRAW UP THE GAS BY TURNING ON THE VALVE AND USING A SYRINGE TO FORCE THE GAS THROUGH TO COMPLETE THE PROCEDURE, AS IT WOULD NOT RELEASE THE GAS AS IT SHOULD WITHOUT USING FORCE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS H.6 AND H.11. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THERE WAS NO PRODUCT RETURNED FOR TESTING. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. 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 NON-CONFORMANCE BASED REVIEW OF THE LOT NUMBER WAS PERFORMED AND A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED COMPLAINT WAS IDENTIFIED. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT NUMBER WAS PERFORMED. A POTENTIALLY RELEVANT COMPLAINTS WAS FOUND. THE COMPLAINT WAS DETERMINED NOT TO BE RELEVANT TO THIS INVESTIGATION. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. 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

THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).