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

Model Number	ARD569204944
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	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Event or Problem Description
On (b)(6)2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated, the particles of the damaged camera fell onto the surgical site.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, h3a device evaluated by manufacturer?, h3b device not eval provide code, h3c if other provide code -explain and h4 manufacture date fields deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 17th november, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated, the particles of the damaged camera fell onto the surgical site.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 17th november, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.It was discovered that the particles of the damaged camera fell onto the surgical site.The issue is considered reportable as the issue can cause serious injury in case of reoccurrence.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 h4 manufacture date: 10/22/2020.Corrected h4 manufacture date: 11/19/2020.Getinge became aware of an issue with one of surgical lights ¿ powerled ii.It was discovered that the particles of the damaged camera fell onto the surgical site.We decided to report the issue in abundance of caution as the issue can cause serious injury 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.The claimed device was not being used for patient treatment or diagnosis when the event took place.According to the photographic evidence, the camera's stop point has been exceeded due to the degradation of the stop of the part ard569201049 facilitated by the manipulation of the light head by the camera handle.Manipulating the light head using the camera handle transmits a significant force to the camera stops.The design change 240302 was raised on march 2024 to improve the stop system.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
On 17th november, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.It was discovered that the particles of the damaged camera fell onto the surgical site.The issue is considered reportable as the issue can cause serious injury in case of reoccurrence.

• Brand Name: 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: 15833685
• Report Number: 9710055-2022-00480
• Device Sequence Number: 20319011
• Product Code: FTD
• UDI-Device Identifier: 03700712412340
• UDI-Public: (01)03700712412340
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/18/2022

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: ARD569204944
• Device Catalogue Number: ARD569204944
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown