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

Model Number	ARDPWT259054A
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	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 29th may, 2024 getinge became aware of an issue with one of surgical lights ¿ powerled ii.It was determined the issue described within complaint is not safety and risk related.On 4th june 2024 further information was provided by getinge technician following the visit at the customer site and device evaluation that light head copula/lens was found falling apart.The copula is cracked completely on a tap side with also missing the tap.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
Event site name: (b)(4).Initial reporter: (b)(6).Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
The correction of d4 version or model #, catalog #, serial #, unique identifier (udi) # deems required.This is based on the internal evaluation.Previous d4 version or model #: ard569201917.Corrected d4 version or model #: ardpwt259054a.Previous d4 catalog #: ard569201917.Corrected d4 catalog #: blank.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).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 determined the issue described within complaint is not safety and risk related.On 4th june 2024 further information was provided by getinge technician following the visit at the customer site and device evaluation that light head copula/lens was found falling apart.The copula is cracked completely on a tap side with also missing the tap.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles 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.There is no information if the claimed device was not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by the subject matter expert.According to the pictures provided the light head must have received not minor shocks but violent shocks and impacts (misuse) with probably another devices.This cover breakage is the result of collisions and misuse.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: 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: 19728256
• Report Number: 9710055-2024-00416
• Device Sequence Number: 20841404
• Product Code: FTD
• UDI-Device Identifier: 03700712408749
• UDI-Public: (01)03700712408749
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: ARDPWT259054A
• Device Catalogue Number: ARD569201917
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown