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

Model Number ARD568370932

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/18/2024

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 january, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated that the spring arm elbow joint metal cover fallen off.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The correction of d4 catalog #, 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 d4 catalog # ard568370932, corrected d4 catalog # ard568370932/ard568370933.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.Getinge became aware of an issue with one of surgical lights - powerled.It was stated that the spring arm elbow joint metal cover fallen off.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Based on an information gathered, defective spring arm ac2000 df dust cover (hm56053311) was replaced.It was established that when the event occurred, the surgical light did not meet its specification due to fall of dust cover, which contributed to the event.The provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.The review of received customer product complaints related to the investigated issue revealed that there were no injuries to a user nor to a patient or operator when this malfunction occurred.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the missing covers from a spring arm is moderate.According to the subject matter expert at the manufacturing site, the incident 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 rev.09, pages 27-29).Additionally, users are requested to pay attention to cracks in plastic parts (ifu 015181 rev.09, pages 20-22).Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• 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: 18587119
• MDR Text Key: 333843760
• Report Number: 9710055-2024-00094
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/26/2024

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 Operator: Health Professional
• Device Model Number: ARD568370932
• Device Catalogue Number: ARD568370932/ARD568370933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1