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

Model Number ARD568350900/ARD568350902

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 18th december, 2023 getinge became aware of an issue with one of surgical lights - powerled.As it was stated, the dust covers were missing from the arms.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - powerled.As it was stated, the dust covers were missing from the arms.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.Based on an information gathered, the spring arm ac2000 df dust cover ((b)(4)) was replaced and device is back in usage again.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, due to dust covers missing, and in this way the device contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of missing cover on powerled and hled surgical lights, there was no event which led to the serious injury.Comparing the number of claimed devices to the number of sold devices worldwide, we can conclude that the failure ratio is moderate for missing covers.A root cause analysis was performed by subject matter experts, and it was established that the dust cover was probably missing due to non-conformity of the metal covers assembly, degradation of the metal covers or 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.Manufacturer initiated also 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 do 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: 18417572
• MDR Text Key: 331583499
• Report Number: 9710055-2023-00990
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/29/2023

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: ARD568350900/ARD568350902
• Device Catalogue Number: ARD568350900/ARD568350902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1