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 AN OPHTHALMIC REGULATOR WAS NOT DISPENSING GAS. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT SCHEDULED PROCEDURE WAS VITRECTOMY SURGERY AND THE EVENT HAPPENED DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE AND THE SAMPLE OF PRODUCTS WERE NOT RETURNED. THEREFORE, TESTING COULD NOT BE 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 REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER WAS PERFORMED. A POTENTIALLY RELEVANT COMPLAINT WAS FOUND (AND REVIEWED AS PART OF THIS INVESTIGATION. THE COMPLAINTS WERE DETERMINED TO BE RELEVANT TO THE INVESTIGATION. A SERVICE HISTORY REVIEW CANNOT BE PERFORMED, AS THE INFORMATION TO CONDUCT THE SEARCH IS UNKNOWN. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. 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).