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

Model Number	ARDPWT229062A
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 26th june, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 500.It was stated that the hood was damaged.Based on photographic evidence the headlight cover was cracked with missing particles.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.
Event or Problem Description
On 26th july, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 500.It was stated that the cover was damaged.Based on photographic evidence the headlight cover was cracked with missing particles.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 initial reporter was distributor.The correction of b5 describe event and problem, d1 brand name, d4 catalog #, d4 version or model #, d4 unique identifier (udi) #, h3a device evaluated by mfg and h3b device not eval provide code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 26th june, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 500.It was stated that the hood was damaged.Based on photographic evidence the headlight cover was cracked with missing particles.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 26th july, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 500.It was stated that the cover was damaged.Based on photographic evidence the headlight cover was cracked with missing particles.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 proce the correction of h3a device evaluated by mfg, h3b device not eval provide code and h3c if other provide code-explain deems required.This is based on the internal evaluation.Previous h3a device evaluated by mfg: no.Corrected h3a device evaluated by mfg: yes.Previous h3b device not eval provide code: device evaluation anticipated, but not yet begun.Corrected h3b device not eval provide code: none.Previous d1 brand name: powerled ii 500.Corrected d1 brand name: maquet powerled ii.Previous d4 catalog # ard569202913.Corrected d4 catalog # none.Previous d4 version or model # ard569202913.Corrected d4 version or model # ardpwt229062a.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 500.It was stated that the cover was damaged.Based on photographic evidence the headlight cover was cracked with missing particles.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.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 the event.There is no information 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 photographic evidence shows cracks on the powerled ii plastic upper cover, these cracks start at the fixing point of the cover and spread towards the center.The cause is probably collisions with other equipment.The covers involved must be replaced.To prevent any incident the powerled ii instructions for use mentions to check that the device has not suffered any impact damage and to check for any chipped or cracked parts during the daily inspections before use.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• 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: 19869784
• Report Number: 9710055-2024-00446
• Device Sequence Number: 7877948
• Product Code: FTD
• UDI-Device Identifier: 03700712406066
• UDI-Public: (01)03700712406066
• 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): 07/31/2024

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: ARDPWT229062A
• Device Catalogue Number: ARD569202913
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown