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

Model Number 568330933

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 16th december, 2020 getinge became aware of an issue with one of surgical lights - powerled.As it was stated, the handle has detached.There was no injury reported, however, we decided to report the issue in abundance of caution as considering the worst case scenario which is unexpected handle detachment and falling off into sterile field or during procedure, the issue may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - power led.As it was stated, the handle has detached.There was no injury reported, however, we decided to report the issue in abundance of caution as considering the worst case scenario which is unexpected handle detachment and falling off into sterile field or during procedure, the issue may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as the handle shouldn't detach from the device and it contributed to incident in that way.There is no information if at the time when the event occurred the device was or was not being used for patient treatment.The results of the torque and tensile tests shows that the handle can withstand a load of 100 n and comply with the iec standard 60601-2-41 ed 2.The separation of the central handle was caused by a deterioration of the handle holder, due to excessive loads (100 n) applied on the handle.To prevent such incident, the installing or removing of the sterilizable handle is described in the user manual power led.Indeed, it is mentioned to check the correct locking of the handle hence its correct fastening onto the light.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).

Event Description

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

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

• 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: 11055867
• MDR Text Key: 241252489
• Report Number: 9710055-2020-00520
• 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
• Report Date: 03/19/2021

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: 568330933
• Device Catalogue Number: 568330933
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/11/2021; 02/22/2021
• Supplement Dates FDA Received: 02/05/2021; 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1