VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. PER THE VISCOUS FLUID CONTROL PAK DIRECTIONS FOR USE, THE DESCRIPTION OF INTENDED USE IS THE FOLLOWING: THE SYSTEM® VISCOUS FLUID CONTROL (VFC) PAK WITH ENGAUGE® RADIO FREQUENCY IDENTIFICATION (RFID) PROVIDES THE NECESSARY ACCESSORIES TO PERFORM ONE (1) SILICONE OIL INJECTION OR EXTRACTION PROCEDURE. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THERE WAS ALSO NO SPECIFIC IMAGES OR EVIDENCE PROVIDED TO ASCERTAIN CAUSALITY AND CONFIRM THIS REPORTED EVENT. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED AS A SAMPLE WAS NOT RECEIVED AND THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. AS THE ROOT CAUSE IS UNKNOWN, THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT CANNOT BE DETERMINED. THE ROOT CAUSE FOR THIS COMPLAINT IS NOT KNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. CURRENT TRACKING INDICATES NO ADVERSE TREND FOR THIS LOT FOR THIS EVENT. IN-PROCESS CONTROLS ARE ESTABLISHED TO ENSURE EACH FINAL ASSEMBLY ACCEPTANCE CRITERIA ARE MET PRIOR TO RELEASE. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND 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 HEALTH CARE PROFESSIONAL REPORTED THAT THE TUBING WAS MADE FOR REMOVAL AND NOT FOR INSERTION AND THAT IT WAS NOT ERGONOMIC (HE HAD TO HOLD IT WITH BOTH HANDS) DURING SURGERY. THE PROCEDURE DETAILS WERE UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.