MAUDE Adverse Event Report: MAQUET SAS HANAULUX 3000; LAMP, SURGICAL

Model Number ARD567902999

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 8th december, 2020 getinge became aware of an issue with hanaulux 3000 surgical light.As it was stated, detachment of sterilizable handle holder occurred and one screw inside its attachment was missing.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with hanaulux 3000 surgical light.As it was stated, detachment of sterilizable handle holder occurred and one screw inside its attachment was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.There is no information if upon the event occurrence, the device was or 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.This incident is probably due to repeated excessive torques (> 100 n), or to mechanical shocks.We remind users that the light head has to be gently manipulated.We also recommend checking if the cleaning products and processes for this operating room are conform to maquet recommendations.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.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: HANAULUX 3000
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11063489
• MDR Text Key: 223457515
• Report Number: 9710055-2020-00521
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567902999
• Device Catalogue Number: ARD567902999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1