Updated sections: d10,g4,g7,h2,h3,h6,h10 internal complaint number: (b)(4) trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period jul 2019 through june 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.Testing of actual/suspected device: (10/13/22) the device was returned to the factory for evaluation on (b)(6) 2021.An investigation was conducted on (b)(6) 2021.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.The pin of the device was observed to be a brown colored indication of rust.The engraved numbers as well as the maquet emblem was observed to be discolored as well.A visual inspection was conducted.Signs of clinical use and slight evidence of blood was observed.The engraved maquet was observed to be a rust color as well as on the engraved # =200501.Based on the returned condition of the device, the reported failure "corrosion" was confirmed.
|