MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS HFD100 - ORT400 IMPERIAL SKULL CLAMP ASSEMBLY

Model Number HFD100 - ORT400 IMPERIAL

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Post-operatively, the neurosurgeons stated that the skull clamp rocker arm (2 pin side) was likely not fully seated due to the position of the patients head.It was likely that the rocker arm only engaged on one pin and achieved a pressure reading secured enough to proceed to drape.When the drape was applied, the pressure applied to secure it forced the rocker into its proper position (engaging the second pin), which lowered the pressure and resulted in the slippage.The skull clamp was used on the subsequent case and additional cases the following days with no issues observed according to the neurosurgeons.The entire head fixation device was returned for further evaluation.Upon evaluation, the device was comprised of a skull clamp, linkage assembly, and adapter assembly.The linkage and adapter assemblies were inspected, free of damage, and found to meet specification.The torque screw in the skull clamp component was removed and tested to verify output.The pressure imparted by the torque screw was within specification at all required outputs based on measurements taken.The remainder of the skull clamp assembly did not exhibit any excess movement or component wear.Overall, the head fixation device was in working condition and suitable for continued use.Based upon examination of the returned device and interview with the physician involved in the incident, it is probable that user error caused or contributed to the reported event.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer, in response to internally identified issues regarding failed electronic submissions through webtrader.

Event Description

At the beginning of a craniotomy procedure on (b)(6) 2021 the patient's head shifted downward when the surgeon applied the adhesive barrier of the drape to ensure full contact with the surgical site for proper asepsis.The surgeon lifted the drape and readjusted the hfd100 skull clamp.The surgeon discovered that the torque screw pressure had dropped below the original application amount.The surgeon proceeded to adjust the pressure upwards via the torque screw until the pressure was satisfactory to hold the patient in a secured position.The procedure was continued as planned and there were no bruising, lacerations or other indications typical of a skull clamp slippage.

• Brand Name: IMRIS HFD100 - ORT400 IMPERIAL SKULL CLAMP ASSEMBLY
• Type of Device: SKULL CLAMP
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer (Section G): IMRIS - DEERFIELD IMAGING, INC; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer Contact: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13425026
• MDR Text Key: 295968957
• Report Number: 3010326005-2021-00006
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K103493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HFD100 - ORT400 IMPERIAL
• Device Catalogue Number: 119629-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2019
• 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 Age: 9 YR