MAUDE Adverse Event Report: MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH HEXAPOD EVO RT SYSTEM; COUCH, RADIATION THERAPY, POWERED

Model Number P10603-100

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2014

Event Type  malfunction  

Event Description

There has not been an adverse event.The customer has reported that when they pushed the table top down on the head side there was a shift of 10cm.The screws under the table top which hold the hexapod in position were unscrewed.The screws have been tightened by the customer, fixing the problem.

Manufacturer Narrative

The manufacturer's investigation is still on-going.Elekta will provide an update once the investigation has been completed.

Manufacturer Narrative

The manufacturer has concluded its investigation.It must be assumed that for this case the service engineer performing the installation on site did not apply the torque as specified in the service manual (20 nm) when mounting the hexapod.This may have been caused due to the apparently very small insertion-depth of the thread of the screw which may have been justified as [?]too small' by the service engineer to apply the specified torque.During the clinical operation of the device, the screws have become loose and then detached due to dynamic load-changes that normally must be expected at application.A risk assessment was conducted which concluded that the current overall design of the device inherits a risk.The risk was classified as 'undesirable'.The original screws shall be replaced with the hexapod mounting kit 03-999-1142.(b)(4) will inform the customers about the situation.The screws shall be checked by the customer.If any screw is loose the system must be put out of service.A service engineer shall tighten the screws with the specified torque.(b)(4) will introduce the new screws as mandatory safety modification.Both (b)(4) are currently being prepared.The new screws have already been introduced to the hexapod series production.This is the manufacturer's final report.Device evaluated by mfr: completed.Corrected - ticked recall.

• Brand Name: HEXAPOD EVO RT SYSTEM
• Type of Device: COUCH, RADIATION THERAPY, POWERED
• Manufacturer (Section D): MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH; robert-bosch-strasse 8; schwabmunchen, 8683 0; GM 86830
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 3700636
• MDR Text Key: 18867215
• Report Number: 9710332-2014-00002
• Device Sequence Number: 1
• Product Code: JAI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P10603-100
• Device Catalogue Number: P10603-900, P10603-911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 03/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2014
• 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