MAUDE Adverse Event Report: MAQUET SAS AXCEL; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD567501985

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 19th april, 2021 getinge became aware of an issue with axcel surgical light.The sterilizable handle detached.There was no injury reported however we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with axcel surgical light.The sterilizable handle detached.There was no injury reported however we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.It was established that when the issue occurred, the light head did not meet its specification and it contributed to the event as the handle shouldn¿t detach.There is no information if in the time when the issue occurred, the device was or was not being used for patient treatment.During the investigation it was found that there is no apparent trend with the issue at hand and that the reported malfunction has never lead to serious injury or worse.According to the statement of service technician, the handle fell due to impact into another piece of equipment.Therefore, we conclude that the root cause is misuse of the device.We believe the related devices are performing correctly in the market.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: AXCEL
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11715365
• MDR Text Key: 247564642
• Report Number: 9710055-2021-00145
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD567501985
• Device Catalogue Number: ARD567501985
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/26/2021
• Patient Sequence Number: 1