T.W. POWER SUPPLY
Received Aug 24, 2021 · Event occurred Aug 4, 2021
Report 2242352-2021-00694 · MDR key 12363358
Device
Generic name
Apparatus, Cautery, Radiofrequency, Battery-powered
Model number
T.W. POWER SUPPLYCatalog number
C-VH-3010
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
N/A.
Additional Manufacturer Narrative
INTERNAL COMPLAINT NUMBER: (B)(4). ANALYSIS OF PRODUCTION: (3331/213/67) THE REPORTED DEVICE IS AN OEM DEVICE. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE REPORTED SERIAL 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) THIS IS AN OEM DEVICE AND THE LOT/SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, A QUERY OF SIMILAR COMPLAINTS FOR THE SERIAL NUMBER AND THE REPORTED FAILURE MODE WAS NOT PERFORMED. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD (B)(6) 2019 THROUGH (B)(6) 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.
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.
Description of Event or Problem
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING C-VH-3010, THEY STATED THAT HEMOPRO POWER SOURCE MODEL VH-3010 WITH SERIAL NUMBER (B)(4) THAT THEY WERE INSPECTING SHOWED THAT THE LED LIGHT GOES ON AND OFF DURING USE. NO PATIENT INVOLVEMENT.