COUPLER 19.5MM 5:4 AUTOCLAVABLE HD

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE COUPLER HAD AN INCORRECT SERIAL NUMBER COMPARED WITH THE SAP INFORMATION. COUPLER SHOWS PART NO: 72200315 AND SERIAL NO: (B)(4) BUT SAP IDENTIFIES THAT SERIAL NUMBER ONLY FOR PART NO: 72200422. INCIDENT OCCURRED DURING A FUNCTIONALLY CHECK; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative

THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION FOUND THE FOCUS RING TO BE OF A NATURAL SILVER ALUMINUM APPEARANCE AND THE LASER PRINTED PRODUCT NUMBER WAS CONFIRMED TO BE 72200315. A DIMENSIONAL EVALUATION FOUND THE HEIGHT OF THE FOCUS RING TO BE 0.734 INCHES. A REVIEW OF THE PRODUCT PRINTS FOUND THE FOCUS RING HEIGHT AND MATERIAL FINISH TO BE OUT OF SPECIFICATION WITH PRODUCT NUMBER 72200315, BUT WITHIN SPECIFICATION OF PRODUCT NUMBER 72200422. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. A REVIEW OF PROVIDED IMAGE CONFIRMED THAT THE DEVICE AND SAP DO NOT MATCH UP WITH THE SAME INFORMATION. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE WAS TRACED TO MANUFACTURING. A COMPLAINT NOTIFICATION WAS SENT TO SUPPLIER QUALITY TO MITIGATE FUTURE RECURRENCE OF THIS ISSUE.