MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS HFD100; SKULL CLAMP

Model Number HFD100

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Skin Tears (2516)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The torque screw and skull clamp table adapter were returned for evaluation.The torque screw was found to be functioning within specifications.The table adapter was found to be seized and full clamping could not be achieved.The adapter was unable to be disassembled for further inspection, but the seizing was most likely caused by internal deformation in the internal part, potentially by application of excess force or cross-threading.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

During a patient procedure on (b)(6) 2019, two neurosurgeons noticed the loose fit of the hfd100 skull clamp assembly.The patient's head moved during drilling however, the patient did not sustain any injuries other than skin damage.

• Brand Name: IMRIS HFD100
• 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: 13441555
• MDR Text Key: 296045792
• Report Number: 3010326005-2019-00041
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: 00857534006011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HFD100
• Device Catalogue Number: 113803-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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: 5 YR
• Patient Sex: Female
• Patient Weight: 17 KG