It was reported to richard wolf "on (b)(6) 2021, fibrous ureteroscopic holmium laser lithotripsy was performed.In the process of lithotripsy, the fibrous ureteroscope failed to bend suddenly and kidney stones could not be found, so the operation was aborted.No information is known about the patient's state of health.".
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Follow-up report #1 is to provide fda with missing information (results of the device evaluation/investigation), new information, and changed information.The following is the results of the device investigation/evaluation as reported by the manufacturer: using process: on (b)(6) 2021, fibrous ureteroscopic holmium laser lithotripsy was performed.In the process of lithotripsy, the fibrous ureteroscope failed to bend suddenly and kidney stones could not be found, so the operation was aborted.Detail of the investigation: after checking, this scope had problem during operation, so the operation was aborted.After that, hospital sent it for a third party company for repair, now it is in normal use.Analysis of cause: normal wear.Instructions for use: the hospital found a third party who carried out the repair himself.The instrument has signs of third-party repair, as a result of which it does not correspond to the specifications given by richard wolf gmbh and it can be ruled out that the instrument was delivered in this condition.This means that richard wolf is no longer the manufacturer of the product.All claims against richard wolf are extinguished by the third-party repair.Product risk: the hospital found a third party who carried out the repair himself.The instrument has signs of third-party repair, as a result of which it does not correspond to the specifications given by richard wolf gmbh and it can be ruled out that the instrument was delivered in this condition.This means that richard wolf is no longer the manufacturer of the product.All claims against richard wolf are extinguished by the third-party repair.Richard wolf gmbh considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation(rwmic) submitting report on behalf of rwgmbh report.
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