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

Model Number ARDPWT229084A

Device Problem Detachment of Device or Device Component (2907)

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) 2021 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the screw fell into sterile field.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or injury.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated that the screw fell into sterile field.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or injury.The screw was replaced by ssu technician and the device was brought back to work.It was established that when the event occurred, the surgical light did not meet its specification due screw falling into sterile field, 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 falling off particles onto sterile field occurrence is moderate.Loose screws were detected on the spring arm cover.These screws attach the covers on the spring arm structure.According to the subject matter expert at the manufacturer the manufacturer of the spring arms, ¿ondal¿, led several tests on a spring arm performing 20.000 cycles of up and down movement.The test with a loosen screw, with a complete turn back, shows that it is the only case where the screw continue to loosen.Based on the analysis of the cases reported, several cases were detected, all delivered in the same hospital, in a period less than 1 year after the installation, the other cases were detected more than 1 year after the installation.The cases detected after more than 1 year after the installation correspond to a lack of inspection during the yearly preventive maintenance.The loosening detected on a period less than 1 year after the installation probably corresponds to a manufacturing issue, due to an incorrect initial tightening on the production line.In the case which is being investigated herein, the issue was detected less than 1 year after the installation.It was confirmed that the spring arm was equipped with new tuflok coated screws.However, based on subject matter expert statement, the most probable root cause still corresponds to the manufacturing issue.So far this case remains isolated.Supplier of the spring arm will be informed about this new issue and further new actions will be engaged in case of other reported cases.To prevent the loosening and the fall of the screw, the technical manuals indicate to check all the fixing screws and to check the hold of the spring arm covers during yearly preventive maintenance.The screw have a long threading, its loosening is visually detectable during cleaning or during yearly preventive maintenance.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's reference number ot (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: 13117528
• MDR Text Key: 282965552
• Report Number: 9710055-2021-00387
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDPWT229084A
• Device Catalogue Number: ARDPWT229084A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1