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

Model Number ARDPWD259001A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated the light head of the device was loose on the connection with its fork and there was a possibility of light head detachment.There was no injury reported however we decided to report the issue based on the potential as a light head falling down might led to serious injury or worse.

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

Event Description

On 27th of april 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated the light head of the device was loose on the connection with its fork and there was a possibility of grinding during movement, creating risk of detachment of filings.There was no injury reported, however, we decided to report the issue based on the potential and any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light - powerled.As it was stated the light head of the device was loose on the connection with its fork and there was a possibility of grinding during movement, creating risk of detachment of filings.There was no injury reported, however, we decided to report the issue based on the potential and any particles falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification, since grinding could be considered as technical deficiency, and in this way device contributed to event.There is no information if the device was or was not being used for patient treatment at the time when the event occurred.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.The problem with the stops rotation is due to a lack of contact area between the stops.These stops realized with screw heads seem to be too short and become ineffective over time.The result is that the light can rotate freely, unplugging the cables and eventually creating some metal fillings.In september 2011, maquet sas has changed these screws in the production line but has not noticed any adverse outcome.Before this date, the screws were a bit longer, hence the stops stronger and should not be concerned by this problem.This issue is followed through the capa 464134.The purpose of this submission is also to provide a correction of describe event or problem section.This is based on the result of internal review.#b5: previous describe event or problem: on 27th of april 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated the light head of the device was loose on the connection with its fork and there was a possibility of light head detachment.There was no injury reported however we decided to report the issue based on the potential as a light head falling down might led to serious injury or worse.Corrected describe event or problem: on 27th of april 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated the light head of the device was loose on the connection with its fork and there was a possibility of grinding during movement, creating risk of detachment of filings.There was no injury reported, however, we decided to report the issue based on the potential and any particles falling off into sterile field or during procedure may cause contamination.

• 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: 11752381
• MDR Text Key: 248190079
• Report Number: 9710055-2021-00165
• 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: 09/21/2021

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: No Information
• Device Model Number: ARDPWD259001A
• Device Catalogue Number: ARDPWD259001A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 05/11/2021; 08/31/2021
• Supplement Dates FDA Received: 06/01/2021; 09/21/2021
• Patient Sequence Number: 1