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

Model Number ARD568371939

Device Problem Material Erosion (1214)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 getinge became aware of an issue with powerled surgical light.The connection between the fork and the headlight was 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

Additional information will be provided following the conclusion of the investigation.The correction of h4 device manufacture date field deems required.This is based on the internal evaluation.Previous h4 device manufacture date 18th april 2018 corrected h4 device manufacture date 3rd may 2018.

Event Description

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

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with powerled surgical light.The connection between the fork and the headlight was 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.

Event Description

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

Manufacturer Narrative

The correction of d4 serial #, h4 manufacture date and h10 conclusion deems required.This is based on the internal evaluation.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Previous h4 manufacture date: 2018-05-03.Corrected h4 manufacture date: 2016-07-21.Previous h10 conclusion: getinge became aware of an issue with powerled surgical light.The connection between the fork and the headlight was 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.Corrected h10 conclusion: getinge became aware of an issue with powerled surgical light.The connection between the fork and the headlight was 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.According to the information obtained from the service unit, the device has been repaired by the installation of repair kit ((b)(4)- pwd fork lexan protection tape kit) and replacement of the faulty fork ((b)(4) - pwd/hld 700 -rep.Kit for end stop cupola).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.

• 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: 11813155
• MDR Text Key: 250258147
• Report Number: 9710055-2021-00183
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568371939
• Device Catalogue Number: ARD568371939
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1