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

Model Number	ARD568370935
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 30th september, 2024 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the dome detached from the light.The screw that secure the dome with arch has come loose and one of the screws was broken in the thread.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of headlight during procedure could lead to serious injury and falling of screw or it particles into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 30th september 2024 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the dome detached from the light.The screw that secures the dome with arch has come loose and one of the screws was broken in the thread.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of headlight during procedure could lead to serious injury and falling of screw or its particles into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The initial reporter was biomedical technician.The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 30th september, 2024 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the dome detached from the light.The screw that secure the dome with arch has come loose and one of the screws was broken in the thread.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of headlight during procedure could lead to serious injury and falling of screw or it particles into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 30th september, 2024 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the dome detached from the light.The screw that secures the dome with arch has come loose and one of the screws was broken in the thread.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of headlight during procedure could lead to serious injury and falling of screw or it particles into sterile field or during procedure may cause contamination.Getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the dome detached from the light.The screw that secures the dome with arch has come loose and one of the screws was broken in the thread.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of headlight during procedure could lead to serious injury and falling of screw or its particles into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.The claimed device was not being used for patient treatment or diagnosis when the event took place.According to the conclusion of the analysis the gap between the fork and the headlight was caused by a loosening of the bracket fixing screws over a long period of time due to a lack of thread-locking patch on 3 screws in the production line.To prevent any safety issue related to a loosened connection between the fork and the headlight the user manual mentions to check the headlights for chipped paint, impact marks and any other damage and to perform yearly preventive maintenance.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: POWERLED
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 20365996
• Report Number: 9710055-2024-0000545
• Device Sequence Number: 14425565
• Product Code: FSY
• UDI-Device Identifier: 03700712403171
• UDI-Public: (01)03700712403171
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568370935
• Device Catalogue Number: ARD568370935
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown