This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.4 devices were not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.3 devices were evaluated in the field and the issue was confirmed; 2 devices had broken/damaged components and the other device had an electrical short.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.
|