CHATTANOOGA APPLICATOR 9CLS 5X200MW 1040MW
Received Jul 9, 2019 · Event occurred Jun 12, 2019
Report 3012446970-2019-00019 · MDR key 8772707
Product problems
- Temperature Problem
- Temperature Problem
Patient
Not reported
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
ONE LASER APPLICATOR (PART NUMBER 27812, SERIAL NUMBER (B)(4)) WAS RETURNED ALONG WITH VECTRA GENISYS BASE UNIT (PART NUMBER 2784, SERIAL NUMBER (B)(4)). NO FAULT WAS FOUND WITH THE BASE UNIT; THE PRODUCT MET SPECIFICATIONS AND DID NOT MALFUNCTION. THE LASER APPLICATOR WAS OBSERVED TO HAVE A DIRTY / SCRATCHED LENS, THE LASER PRINTED HANDLE WAS NOT FLUSH, AND THE CALIBRATION STICKER WAS NOT FROM DJO. FUNCTIONAL TEST YIELDED AN ERROR 201: LASER OUTPUT TOO HIGH. THIS FOLLOWED WITH CHECKS YIELDING RESULTS OF "FIVE LASERS OK" FOR LASER ONLY TESTS (1190 MW, 1180 MW). NO ISSUES WERE FOUND WHEN OPENING THE HEAD AND BOTTOM CABLE TO CHECK FOR ALTERATIONS AND DAMAGED WIRES. THE LASER APPLICATOR HAS BEEN IN THE FIELD FOR 5+ YEARS WITH NO ANNUAL CALIBRATION. A DEFINITIVE ROOT CAUSE TO THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT "GOT A SENSATION OF BEING BURNED, CAUSED BLISTERS AND IRRITATION ON PATIENT". NO FURTHER INFORMATION WAS PROVIDED.