MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LAMP, SURGICAL

Catalog Number ARD569202911

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/05/2022

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) 2022, getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the hoop brake cover was missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Event Description

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

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of #manufacture date field deem required.This is based on the internal evaluation.H4 previous manufacture date: 15.12.2020.Corrected manufacture date: 16.12.2020.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the hoop brake cover was missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Based on getinge technician statement, the customer ordered parts for replacement.Based on the information collected, it was established that when the event occurred, surgical light did not meet its specification due to cap which was missing silicone cap which could be considered as technical deficiency, and in this way device contributed to event.There is no indication if the device was being used for patient treatment at the time when the event occurred.When reviewing reportable events for this type of issues we were able to establish that the received incident of missing silicone cap occurs at low ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As stated by subject matter expert at manufacturer¿s, the cleaning of the device, and particularly the wiping of the device may lead to a partial dismantling of the silicone cap.A maintenance intervention may also be at the origin of an improper positioning of this cap.This partial dismantling may lead to a fall of the silicone cap during the cleaning, or during a surgical procedure.To prevent any incident, the powerled ii user manual mentions: do not use a damaged device because it may lead to a risk of injury for users r a risk of infection for patients.Check the proper position caps and cover during the daily inspections before se.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.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 ot (b)(4).

• Brand Name: POWERLED II
• Type of Device: LAMP, SURGICAL
• 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: 14336106
• MDR Text Key: 291210577
• Report Number: 9710055-2022-00150
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD569202911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1