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

Catalog Number ARD569201915

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/10/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of surgical lights - powerled ii.The screw fell off the arm.There was no injury reported however we decided to report the issue basing on potential as any parts falling off into sterile field or during procedure may be a source of contamination.

Manufacturer Narrative

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

Manufacturer Narrative

The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 2019-06-25; corrected h4 2019-06-26.Getinge became aware of an issue with one of surgical lights - powerled ii.The screw fell off the arm.There was no injury reported however we decided to report the issue basing on potential as any parts falling off into sterile field or during procedure may be a source of contamination.According to the service technician, the screw was refitted by the customer¿s biomedical engineer.It was established that when the event occurred, the surgical light did not meet its specification due to fall of the screw from a spring arm, which contributed to the event.Provided information points that upon the event occurrence the device was 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 these particular malfunctions occurred.The failure ratio of investigated issue is considered moderate.The supplier of spring arms (ondal) led several tests on a spring arm and performed 20000 cycles of up and down movement.The test with a loosened screw with a complete turn back, shows that it is the only case where the screw continue to loosen.The loosening detected on a period less than 1 year after the installation therefore appears to correspond to a manufacturing issue, due to an incorrect initial tightening during assembly.The cases detected after more 1 year after the installation, in contrast correspond to a lack of inspection during the yearly preventive maintenance.This because during such maintenance such loose fastener would be detected, since the maintenance schedule requires a visual check.The claimed device was over two years in use till the issue occurred, moreover, was not under getinge service agreement, therefore, the root cause is related to user error.To prevent the loosening and the fall of the screw, the maintenance manual indicates to check all the fixing screws and to check the holding in place of the spring arm covers.The screw has a long threading, to ensure that any loosening is visually detectable during cleaning or during maintenance inspection.As improvement measure since october 2019 the spring arms covers are assembled on the product line with tuflok coated screws.In any case, by design, the nylon patch of these screws acts as a mechanical locking and prevents the loosening and the fall of the screw.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 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: 13009612
• MDR Text Key: 282268785
• Report Number: 9710055-2021-00374
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD569201915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1