Event Type Malfunction Patient Outcome Required Intervention
An evaluation was performed on the returned product and could not confirm the customer complaint for the tip detaching. The evaluation showed the scope has been sent to an unauthorized repair shop for repair. The scope shows to have a different tip assembled on it and there is epoxy at the base of the needle where the weld joint is supposed to be. Since this scope has been repaired by an unauthorized facility no further investigation is required. (b)(4).
Patient admitted for hip arthroscopy. During procedure distal end of scope detached from the main body of scope. Patient later re-admitted for removal of scope part; this was not successful and decision was made to end the procedure and re-admit patient at a later date for removal of minor fragment. No injury to patient.