MAUDE Adverse Event Report: MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARDPWD259001A

Device Problem Material Erosion (1214)

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

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 our surgical lights ¿ powerled.As it was stated, the stop pin was damaged.Such issue can lead to grinding during movement, creating risk of detachment of filings.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.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated, the stop pin was damaged.Such issue can lead to grinding during movement, creating risk of detachment of filings.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.It was established that when the event occurred, the surgical light did not meet its specification due to broken rotation stop on the lighthead, which contributed to the event.Provided information indicate that upon the event occurrence, the device was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of broken rotation stop pin on the lighthead occurrence is low.According to the subject matter expert at the manufacturer¿s, the problem with the stops rotation reported on some pwd700 and hled 700 light heads is due to a lack of contact area between the stops.These stops realized with screw heads seem to be too short and become ineffective over time.The result is that the light can rotate freely, unplugging the cables and eventually creating some metal fillings.In september 2011, maquet sas has changed these screws in the production line but has not noticed any adverse outcome.Before this date, the screws were a bit longer, hence the stops stronger and should not be concerned by this problem.This issue is followed through the capa#464134.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 13838495
• MDR Text Key: 287586419
• Report Number: 9710055-2022-00087
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 03700712404383
• UDI-Public: 3700712404383
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDPWD259001A
• Device Catalogue Number: ARDPWD259001A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1