MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2005; LAMP, SURGICAL

Model Number HM56076818

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of surgical lights - hanaulux 2005.As it was stated, the sterilizable handle holder was defective leading to inability to lock the sterilizable handle, moreover, small particles of the mechanism were found on a floor.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may lead to contamination.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hanaulux 2005.As it was stated, the sterilizable handle holder was defective leading to inability to lock the sterilizable handle, moreover, small particles of the mechanism were found on a floor.There was no injury reported however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.Upon the event occurrence the device was not being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.According to the details provided, two possible causes could explain this event: - due to the age of the product (about 17 years) it is possible that the circlips broke.- another possibility is that the circlips disengaged for an unknown reason yet.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: HANAULUX 2005
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10600727
• MDR Text Key: 208991025
• Report Number: 9710055-2020-00378
• Device Sequence Number: 1
• Product Code: FTD
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HM56076818
• Device Catalogue Number: HM56076818
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1