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

Model Number ARDPWT259052A

Device Problem Material Erosion (1214)

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 17th june, 2021 getinge became aware of an issue with powerled ii surgical light.As it was stated, metal filings were falling off of arm.There was no injury reported however we decided to report the issue based on the potential and any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with powerled ii surgical light.As it was stated, metal filings were falling off from spring arm.There was no injury reported, however, we decided to report the issue based on the potential as any particles falling off into sterile field or during procedure may cause contamination.According to the information provided by the service unit, the device has been repaired by replacement of spring arm and monitor holder.It was established that when the event occurred, the surgical light did not meet its specification due to the issue of metal savings falling off from spring arm, which contributed to the event.It is unknown if upon the event occurrence the device was or 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 is very low.As stated by subject matter expert at manufacturer, the metal shaving at the junction of the spring arm is caused by the rubbing of the stop screws inside the spring arm.The evaluation has shown that in certain conditions, the minimum gap between the spring arm and screen holder stops is not sufficient in order to rotate freely.This is the root cause of this grinding.A modification is already engaged to correct this problem.As well this issue has been evaluated in an hhe meeting, and it was agreed to put this issue under surveillance for the following months.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer's reference number ot484656.

• Brand Name: POWERLED II
• 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: 12057778
• MDR Text Key: 258065207
• Report Number: 9710055-2021-00233
• Device Sequence Number: 1
• Product Code: FTD
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDPWT259052A
• Device Catalogue Number: ARDPWT259052A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1