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

Model Number	ARDPWT229062A
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	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Initial reporter was clinical engineer.Event site telephone: (b)(6).H3 other text : device was not returned to the manufacturer.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the handle of the monitor came off during surgery, this event did not cause any delays.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 serious injury.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The correction of d4 version or model #, catalog #, serial #, h3a device evaluated by manufacturer?, h3b device not eval provide code, h3c if other provide code -explain, h4 manufacture date fields deems required.This is based on the internal evaluation.Previous d4 version or model #: ard569241917/ard569242913.Corrected d4 version or model #: ardpwt229062a.Previous d4 catalog #: ard569241917/ard569242913.Corrected d4 catalog #: blank.Previous d4 serial #: (b)(6).Corrected d4 serial #: 500100.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: 2020-08-11.Corrected h4 manufacture date: 2022-08-23.Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the handle of the monitor came off during surgery, this event did not cause any delays.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 serious injury.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 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 detachment between aluminum cylinder and the handle support is probably due to mechanical shocks, collisions or excessive efforts.To prevent any similar incident: - during the manufacturing the parts are degreased, - the quantity of the instant adhesive gel deposited is checked, - the adhesive bonding is checked by manual traction during the manufacturing, - the user manual # (b)(4) xs/xd flat screen monitors holders mentions to check the condition of the serializable handle.As part of continuous improvement a request change has been launched (# (b)(4)).The design team is currently studying various solutions.The new design will eliminate the need for bonding between the aluminum cylinder and the handle support.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• 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: 17305529
• Report Number: 9710055-2023-00510
• Device Sequence Number: 17938293
• Product Code: FTD
• UDI-Device Identifier: 03700712406066
• UDI-Public: (01)03700712406066
• 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): 07/12/2023

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: ARD569241917/ARD569242913
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown