T.W. POWER SUPPLY

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

TRACKWISE #(B)(4). UPDATED SECTION: G4, G7, H2, H6, H10 ANALYSIS OF PRODUCTION: (3331/213/67) THE REPORTED DEVICE IS AN OEM DEVICE. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE REPORTED SERIAL/LOT NUMBER. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS AND THERE WERE NO NON-CONFORMANCES IDENTIFIED FOR THE MANUFACTURING BATCH HISTORICAL DATA ANALYSIS: (4109/213/67) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINTS WAS REPORTED FOR THE SAME SERIAL/LOT NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD NOV 2019 THROUGH OCT 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. COMMUNICATION/INTERVIEWS: (4111/213/67) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, T.W. POWER SUPPLY WAS NOT WORKING PROPERLY. THEY WERE REQUIRED TO TURN UP SETTING "REALLY HIGH" TO GET THE ENERGY TO WORK WITH THE HP DEVICE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT.

Additional Manufacturer Narrative

TRACKWISE ID (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.