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

Model Number ARD568330933

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with one of surgical lights- powerled.As it was stated, the handle ring cracked and particles were missing.There was no injury reported however we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure might cause contamination.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights- powerled.As it was stated, the handle ring cracked and particles were missing.There was no injury reported however we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure might cause contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to incident.At the time when the event occurred the device was not being used for patient treatment.When reviewing similar reportable events for the same device, we have been able to find several similar fault descriptions compared to the situation investigated here, in none a serious injury or worse occurred.There is no trend observed for this failure mode.The most probable root cause is a combination of chemical stress and excessive radial force applied on the handle.However, it was decided to implement modification to replace the material used on sterilizable handle¿s interface.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 reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer 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
• MDR Report Key: 9320200
• MDR Text Key: 178196684
• Report Number: 9710055-2019-00330
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568330933
• Device Catalogue Number: ARD568330933
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1