The reported event was confirmed.The root cause of the reported issue was due to isolated to a use-related.The pins on the load cell were bent/twisted.(evidence of a ring being turned too much or in the wrong direction).The load cell assembly was replaced.The servicing was performed as per the test procedure.The device functionating properly and was ready for use.The product would not meet the specifications, and was influenced by the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product when connecting the single patient use, sensica uo ring to the system stand, use a firm, clockwise twisting motion.Do not apply excessive force or torque to the ring or the system's ring interface when connecting the device to avoid damaging components." corrections: d10, h3.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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