MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS HFD100 SKULL CLAMP ASSEMBLY; HEAD FIXATION DEVICE

Model Number HFD100

Device Problem Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 01/04/2018

Event Type  malfunction  

Event Description

During a craniotomy procedure on (b)(6) 2018, a patient was prepped and placed in the prone position.The patient's head was properly seated and fixated in the hfd100 skull clamp assembly.Subsequently, the two-pin rocker arm spun on its own after being locked and the patient sustained a 2-inch laceration that was closed using three staples.The procedure was successfully completed.

Manufacturer Narrative

The hfd100 skull clamp assembly was visually inspected and mechanically tested however, no discrepancies were observed.There is a possibility that user error caused or contributed to the event.Data is not available from the hospital to assess the specific application of the skull clamp to this patient.

• Brand Name: IMRIS HFD100 SKULL CLAMP ASSEMBLY
• Type of Device: HEAD FIXATION DEVICE
• 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: 13425552
• MDR Text Key: 286366225
• Report Number: 3010326005-2018-00003
• Device Sequence Number: 1
• Product Code: HBL
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/08/2018

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HFD100
• Device Catalogue Number: 113802-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2014
• 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: 13 YR
• Patient Sex: Male
• Patient Weight: 96 KG