MAUDE Adverse Event Report: MAQUET SAS POWERLED 500; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARD568410010C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 14th september, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the cover from the joints had sprung out and hit a patient's wrist in the middle of surgery.There was no medical intervention required, no injury or permanent damage to the body structure reported, no delays in surgery.Spring arm cover channel was worn due to incorrect position of the dust cover.Damage of the spring arm covers indicated that the dust covers were not fitted correctly and this might be a reason why they could pop out and fall off.It has been brought to getinge technician attention that night shift hospital engineers have been putting them back in themselves prior to the incident.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 serious injury in case of reoccurrence.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6) hospital.The initial reporter was theatre staff h3 other text : device not returned to manufacturer.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
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.The correction of d4 catalog #, unique identifier (udi) # deems required.This is based on the internal evaluation.Previous d4 catalog # ard568410010c.Corrected d4 catalog # ard568351939/ard568350931.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Getinge became aware of an issue with one of surgical lights powerled 500.It was stated the cover from the joints had sprung out and hit a patient's wrist in the middle of surgery.There was no medical intervention required, no injury or permanent damage to the body structure reported, no delays in surgery.Spring arm cover channel was worn due to incorrect position of the dust cover.Damage of the spring arm covers indicated that the dust covers were not fitted correctly and this might be a reason why they could pop out and fall off.It has been brought to getinge technician attention that night shift hospital engineers have been putting them back in themselves prior to the incident.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 serious injury in case of reoccurrence.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.Device was not being used for patient treatment or diagnosis when the event took place.It was discovered following a service.Subject matter expert established the possible root causes are: non-conformity of the metal covers assembly.Degradation of the metal covers.Improper use (collision with another device) maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (b)(4) to include this dust cover fitting procedure in the technical documentations with all spring arms.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: POWERLED 500
• Common Device Name: 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: 17771652
• Report Number: 9710055-2023-00708
• Device Sequence Number: 20623727
• Product Code: FSY
• UDI-Device Identifier: 03700712402532
• UDI-Public: (01)03700712402532
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ARD568410010C
• Device Catalogue Number: ARD568351939/ARD568350931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown