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

Model Number ARD568371938

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

On 12th july, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.The received customer allegation regarded a non-reportable issue.Further information became available on 15th february 2024 following the inspection visit at the customer site.It was stated the safety segment worn and allowing the cupola to rotate past the stops.The wear of cupola stop screw during use can lead to metal particles falling.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Event site name: (b)(6) hospital initial reporter was getinge technician.Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

The correction of b3 date of event deems required.This is based on the internal evaluation.Previous b3 date of event : 07/12/2023.Corrected b3 date of event : 02/15/2024.The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.On 12th july, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.The received customer allegation regarded a non-reportable issue.Further information became available on 15th february 2024 following the inspection visit at the customer site.It was stated the safety segment worn and allowing the cupola to rotate past the stops.The wear of cupola stop screw during use can lead to metal particles falling.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.It is unknown if the claimed device was or was not being used for patient treatment or diagnosis when the event took place.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 does not propose any further action at this time.

Event Description

Manufacturer's 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: 19150347
• MDR Text Key: 341562672
• Report Number: 9710055-2024-00287
• Device Sequence Number: 1
• Product Code: FSY
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568371938
• Device Catalogue Number: ARD568371938
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 07/12/2024
• Supplement Dates FDA Received: 07/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1