MAUDE Adverse Event Report: MAQUET SAS MAQUET POWERLED II; LAMP, SURGICAL

Model Number	ARDPWT609009A
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	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 2nd may, 2024 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the dust cover from spring arm fell on the floor, when surgeon adjusted light position.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.
Additional Manufacturer Narrative
The correction of d1 brand name, d4 catalog #, d4 unique identifier (udi) #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain, h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2023-12-11.Corrected h4 manufacture date: 2023-12-12.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.Previous d1 brand name: powerled ii.Corrected d1 brand name: maquet powerled ii.Previous d4 catalog # ardpwt609009a.Corrected d4 catalog # none.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #:(b)(4).Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the dust cover from spring arm fell on the floor, when surgeon adjusted light position.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.The provided information indicate that upon the event occurrence, the device was being used for diagnosis purposes.Root cause analysis was performed by the subject matter expert.According to the information provided, the covers have fallen off because they have not been correctly installed.The installation manual 01814 the describes how to fit the covers on the spring arm, it is recommended to follow the instructions in the manual.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)(4).

• Brand Name: MAQUET POWERLED II
• Common Device Name: LAMP, SURGICAL
• 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: 19267026
• Report Number: 9710055-2024-00317
• Device Sequence Number: 15202887
• Product Code: FTD
• UDI-Device Identifier: 03700712422929
• UDI-Public: (01)03700712422929
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: ARDPWT609009A
• Device Catalogue Number: ARDPWT609009A
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown