The hakim valve was returned for evaluation.Device history record (dhr) - lot 3276913 conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected, the silicone housing was cut/torn around the siphon guard, complaint is confirmed.The siphon guard was visually inspected marks were found in the siphon guard.The root cause for the problem reported by the customer, ¿the hakim valve was found broken through "ct "check.¿ is probably due to wrong handling, as noted in the "ifu": silicone has a low cut/tear resistance.Do not use sharp instruments when handling the silicone valve or catheter, use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.
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A facility reported hakim programmable valve was implanted in a patient on (b)(6) 2019, the patient recovered well after the procedure.Several months after the procedure, the patient felt not well, and the hakim valve was found broken through ct imaging.The patient was taken to surgery on (b)(6) 2021 for a shunt revision procedure and implanted with another of the same valve, 823832.
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