TRISTAR 50 ICW

Additional Manufacturer Narrative

H10: H3, H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION OF THE RETURNED INSTRUMENT SHOWS ELECTRODE HAS BEEN DETACHED. NO MANUFACTURING ABNORMALITIES. THE DEVICE WAS PLUGGED INTO THE CONTROLLER AND REGISTERED SETTINGS (1,7). THE WAND WAS ABLE TO GENERATE PLASMA AS INTENDED. THE ELECTRODE HAS BEEN DETACHED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. THE COMPLAINT WAS CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) HITTING THE DEVICE TIP AGAINST A HARD SURFACE. (2) USING THE DEVICE AS A LEVER TO ENLARGE SURGICAL SITE. (3) MECHANICAL DISPLACEMENT OF TISSUE THROUGH APPLIED FORCE.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE METAL ELECTRODE IN THE "TRISTAR 50° IC WAND" FELL INSIDE THE PATIENT. ALL PIECES WERE REMOVED FROM PATIENT WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.