MAUDE Adverse Event Report: MAQUET SAS POWERLED II 500; LAMP, SURGICAL

Model Number ARD569202903

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the safety circlip from the joint of the arms jumped out.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the safety circlip from the joint of the arms failed to hold position.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.According to the information provided by the service technician, the device has been repaired on 4th april 2022.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event due to fault of safety circlip.There is no indication if the device was being used for patient treatment at the time when the event occurred.Comparing the install base and the number of complained devices with a similar issue to the investigated one, we conclude that the failure ratio is very low.The root cause analysis was performed by a subject matter expert and it was concluded the mechanical coupling between the spring arm and the main arm has failed because the circlip was not fully seated in its groove.The root cause is an incorrect fitting during installation or spring arm replacement for maintenance.All the procedure and reminders about the correct fitting of this circlip are detailed in all installation manuals lights where it is involved.This mounting is a critical operation and must be performed according to the rules.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation would have been followed the incident would have been avoided.

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

• Brand Name: POWERLED II 500
• Type of Device: 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: 14014068
• MDR Text Key: 288597428
• Report Number: 9710055-2022-00108
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD569202903
• Device Catalogue Number: ARD569202903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1