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

Model Number ARD568330999

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be available upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) getinge became aware of an issue with one of our surgical light - powerled.As it was stated during inspection of the device technician noticed that handle of the device had been broken off.No information about any injury was provided, however we decided to report this case in abundance of caution as considering the worst case scenario which is unexpected handle detachment and falling off into sterile field or during procedure, the issue may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light - powerled.As it was stated during inspection of the device technician noticed that handle of the device had been broken off.No information about any injury was provided, however we decided to report this case in abundance of caution as considering the worst case scenario which is unexpected handle detachment and falling off into sterile field or during procedure, the issue may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as the handle shouldn¿t detach and it contributed to incident in that way.There is no information if at the time when the event occurred the device was or was not being used for patient treatment.It was noticed that the handle had been broken off by an error in use.As maquet did not receive enough information to conduct the technical investigation, therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: POWERLED
• 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: 11706229
• MDR Text Key: 260957165
• Report Number: 9710055-2021-00141
• 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: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ARD568330999
• Device Catalogue Number: ARD568330999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2021
• Patient Sequence Number: 1