This mdr is being submitted as part of service and repair remediation activities associated with capa (b)(4).The device was returned to the manufacturer for service and repair.The unit was cleaned per protocol.It was noted upon inspection that the returned unit did not meet all specific functional tests.The unit was received with the skull clamp base boss badly chipped from the hospital overtightend the swivel adaptor and the base will need to be replaced; unit was received with the locking mechanism having both rotational and lateral movement; in addition to residue buildup.New component was added to replace worn internal parts; general maintenance and cleaning required.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances related to the reported failure.
|