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

Model Number	ARD568436010A
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	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Initial reporter: (b)(6).Event site name: samodzielny publiczny szpital.The initial reporter was getinge technician.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 5th october, 2023 getinge became aware of an issue with one of surgical lights - powerled.It was stated the cap in the fork rotation axis was missing (catalog no.Ard368324998).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 or serious injury.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d4 catalog #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous d4 catalog # ard568436010a.Corrected d4 catalog # ard568446010a.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.Getinge became aware of an issue with one of surgical lights - powerled.It was stated the cap in the fork rotation axis was missing (catalog no.Ard368324998).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 or serious injury.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.Provided information indicates, that device was not being used for patient¿s treatment when the event occurrence.The issue was found during preventive maintenance.As stated by subject matter expert at the manufacturing site, the most likely root cause of the issue with end cap is an incorrect mounting of the part.The fact that device leaves the factory with such a partial positioning is highly unlikely.The end cap has been removed or reinstalled on site during installation or a maintenance procedure.A shock with another device like a spring arm or main arm cannot be the root cause.This possibility was tested without consequences for the end cap.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number (b)(6).
Additional Manufacturer Narrative
The correction of h6 investigation findings, h6 investigation conclusions fields deems required.This is based on the internal evaluation.Previous h6 investigation findings: operational problem identified/device incorrectly reprocessed/device incorrectly assembled during reprocessing/4231 corrected h6 investigation findings: maintenance problem identified/115.Previous h6 investigation conclusions: cause traced to user/19 corrected h6 investigation conclusions: cause traced to maintenance/51.

• 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: 17910308
• Report Number: 9710055-2023-00751
• Device Sequence Number: 6626918
• Product Code: FSY
• UDI-Device Identifier: 03700712402624
• UDI-Public: (01)03700712402624
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 10/10/2023

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: ARD568436010A
• Device Catalogue Number: ARD568446010A
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 07/01/2024; 02/13/2025
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 07/09/2024; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown