MAUDE Adverse Event Report: ELEKTA LTD PRECISE TREATMENT TABLE; COUCH, RADIATION THERAPY, POWERED

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

A hospital therapist sustained an injury during a manual move of the patient support system whist a patient was loaded.The therapist's fingertip was severed when it was caught between the two end stops on the table tops longitudinal linear bearing.Although the injured user in this case may not regrow their finger nail, generally a full recovery shall be assumed with no long term effect.Finger traps are only a concern during table movement.The risk of injury for a patient is less than the risk to the clinical user as the patient is less exposed to the hazard and shall be observed by the clinician.The clinician will also be overseeing the patient during any table shifts.It is recommended to use motor driven shifts and warnings are provided in the instructions for use manual: warning 4.5: do not use asu until you make sure that there are no objects or persons in the path of movement.Be very careful if you move more than one piece of equipment at a time.If you ignore this warning, you can cause serious injury and damage to the equipment.Warning 4.7: do not let the patient get on the treatment table, or start treatment, before the table top is latched correctly, and the lamps in the brake release buttons are on.If you ignore this warning, you can cause serious injury.Warning 4.8: do not let the patient move off the treatment table, or move it in the longitudinal or lateral direction, until you make sure that the patient does not catch their fingers or body parts in the path of movement.If you ignore this warning, you can cause serious injury and damage to the equipment.Risk assessed as moderate (acceptable harm).

Event Description

One of the customer therapists injured her finger while using the manual longitudinal movement on the treatment table to position the patient for treatment.She injured the top part of her finger when the two longitudinal bearings collided.

• Brand Name: PRECISE TREATMENT TABLE
• Type of Device: COUCH, RADIATION THERAPY, POWERED
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer Contact: pms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 6039440
• MDR Text Key: 57805030
• Report Number: 9617016-2016-00007
• Device Sequence Number: 1
• Product Code: JAI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K983678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physicist
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other