MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2014-03-26 for HEXAPOD EVO RT SYSTEM P10603-100 P10603-900, P10603-911 manufactured by Medical Intelligence Medizintechnik Gmbh.
[18867215]
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.
Patient Sequence No: 1, Text Type: D, B5
[19096516]
The manufacturer's investigation is still on-going. Elekta will provide an update once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[28068279]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710332-2014-00002 |
| MDR Report Key | 3700636 |
| Report Source | 00,05,06 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-02-27 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2014-05-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEXAPOD EVO RT SYSTEM |
| Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2014-03-26 |
| Model Number | P10603-100 |
| Catalog Number | P10603-900, P10603-911 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
| Manufacturer Address | ROBERT-BOSCH-STRASSE 8 SCHWABMUNCHEN, 86830 GM 86830 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-26 |