Model Number HFD100 |
Device Problems
Mechanical Problem (1384); Use of Device Problem (1670)
|
Patient Problem
Laceration(s) (1946)
|
Event Date 12/13/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Further detailed information has been requested by the manufacturer regarding the procedure, patient demographics and final outcome.Analysis of the skull clamp assembly of the hfd was completed by an imris service engineer at the customer site and found no performance issues.The torque screw utilized in the procedure is being returned for analysis to support the investigation; a followup report will be submitted at the investigation conclusion and with any further reportable information received from the customer.
|
|
Event Description
|
A customer reported that the patient suffered a laceration after use of the imris hfd100 head fixation device.It was reported that 80 pounds of pressure was used to pin the patient's head, and that upon removal of the device at the conclusion of the procedure, the skull clamp appeared quite loose and promptly fell off the patient, which caused the laceration.No further details were reported and the manufacturer has requested further information from the customer site.
|
|
Manufacturer Narrative
|
Follow-up information was received from the event reporter at the end user.Section a was updated based on patient information received for this follow-up report.The information received indicates the patient experienced a superficial laceration to the posterior left ear that did not require additional treatment, and that the laceration was observed upon completion of the case as the clinical staff was unpinning the patient.The case was reported to be completed successfully, and there were no modifications to the planned procedure or negative patient consequences.The torque screw used in the head fixation device involved was returned to the manufacturer and met specified requirements for pressure output at all tested intervals.No device malfunction was identified in the head fixation device or torque screw component.The most likely cause of the slippage event relates to pinning or fixation technique.Manufacturers clinical applications team performed in-service training on the device with end users at the customer site on 2024-03-20.
|
|
Search Alerts/Recalls
|