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

Model Number	ARD568443710C
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	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled.Based on photographic evidence the covers was missing from spring arm.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.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, d4 version of model #, d4 catalog #, d4 serial# deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 15th june, 2023 getinge became aware of an issue with one of surgical lights - powerled.Based on photographic evidence the covers was missing from spring arm.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.Corrected b5 describe event and problem: on 15th june, 2023 getinge became aware of an issue with one of surgical lights - powerled.Based on photographic evidence the covers were missing from spring arm.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.Previous d4 version of model # and d4 catalog # ard568443710c.Corrected d4 version of model # and d4 catalog # ard568415010a.Previous d4 serial# (b)(6).Corrected d4 serial# (b)(6).Getinge became aware of an issue with one of surgical lights - powerled.Based on photographic evidence the covers were missing from spring arm.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.According to the information provided by getinge technician, missing covers (ard367825555 & hm56053311) were replaced and the device was returned to use.It was established that when the event occurred, the surgical light did not meet its specification due to missing spring arm covers, which contributed to the reportable situation.It is uknown if the device was or was not being used for the patient treatment upon the event occurrence.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Comparing the number of affected devices by the investigated issue to the install base, complaint ratio is low.As per expertise performed by the subject matter expert at manufacturing site, the possible root causes with regards to the metal spring arm cover 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 (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.Additionally, as stated by the subject matter expert at the manufacturing site, the incident with regards to the plastic cover is due to inappropriate use.To prevent such an issue from reoccurring, the manufacturer¿s recommendation is to follow the instructions from the operating manual concerning arm pre-positioning prior to use (ifu 015181 en 09 pages 27-29).Additionally, users are requested to pay attention to cracks in plastic parts (ifu 015181 en 09 pages 20-22).We believe that if the manufacturer recommendation had been followed the reported situation would have been avoided.Given the findings of this investigation getinge shall continue to monitor for any further events of this nature and does not propose any other action at this time.
Event or Problem Description
On 15th june, 2023 getinge became aware of an issue with one of surgical lights - powerled.Based on photographic evidence the covers were missing from spring arm.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.

• Brand Name: POWERLED
• 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: 17219555
• Report Number: 9710055-2023-00477
• Device Sequence Number: 17695692
• Product Code: FSY
• UDI-Device Identifier: 03700712402532
• UDI-Public: 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): 06/28/2023

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: ARD568443710C
• Device Catalogue Number: ARD568415010A
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown