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

Model Number	ARDPWT629089A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 2nd april 2024 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated, the paint was damaged during assembly due the way the dome was packaged in the shipping box.It was confirmed that the surgical light was used after the installation with this issue present on the device.The designated complaint unit employee established based on photographic evidence that the paint damage occurred on the fork.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.
Additional Manufacturer Narrative
The correction of d1 brand name, d4 catalog#, d4 unique identifier (udi)# fields deems required.This is based on the internal evaluation.Previous d1 brand name: powerled ii.Corrected d1 brand name: maquet powerled i.Previous d4 catalog#: ardpwt629089a.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.As it was stated, the paint was damaged during assembly due the way the dome was packaged in the shipping box.It was confirmed that the surgical light was used after the installation with this issue present on the device.The designated complaint unit employee established, based on photographic evidence, that the paint damage occurred on the fork.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.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.It is unknown if the claimed device was or was not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: the lack of protective foam into the cardboard packaging is probably the cause of these scratches.This default has been detected at the installation.Since november 7th 2023 and through the modification number 220520 the packaging has been improved in order to prevent from happening such issues in the future.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: 19104452
• Report Number: 9710055-2024-00269
• Device Sequence Number: 7736999
• Product Code: FTD
• UDI-Device Identifier: 03700712425050
• UDI-Public: (01)03700712425050
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/15/2024

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: ARDPWT629089A
• Device Catalogue Number: ARDPWT629089A
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown