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

Model Number HFD100

Device Problem Decrease in Pressure (1490)

Patient Problem Laceration(s) (1946)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

On (b)(6)2021, a procedure was being performed and the patient was pinned on the stretcher.When the patient was flipped on the or table into position, the hfd100 skull clamp slipped off.As a result, the pins scratched the patients head causing a minor laceration.The skull clamp was adjusted however, it slipped a second time.The skull clamp was exchanged but it failed to properly clamp on the first time.A second attempt was performed and the clamp worked as normal.The surgeon concluded that the first skull clamp malfunction and the second skull clamp first attempt failure were caused by operator error.The skull clamps and associated torque screws were replaced and returned for further evaluation.

Manufacturer Narrative

The two skull clamps and associated torque screws were inspected and evaluated and both skull clamps functioned as intended.The bottom lock mechanisms appeared to work normally on both clamps and the failure modes were unable to be reproduced.The torque screw associated with the first skull clamp (slip/laceration) was found to be functioning within specification at 40, 60, and 80 lb.However, the settings were found to be out of calibration at the lowest setting of 20 lbs.The underlying cause appeared to be a weakened spring although it did not appear to be related to the slippage.The second torque screw was found to be within calibration and functioned as intended.Based on the investigation, it is difficult to determine the root cause of the slippage but 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.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.

• 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: 13451190
• MDR Text Key: 287286384
• Report Number: 3010326005-2021-00003
• 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: Inspection
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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: 02/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2018
• 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 Weight: 79 KG