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

Catalog Number ARD567912923

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights: powerled ii.It was stated the spring arm rear 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.

Manufacturer Narrative

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

Manufacturer Narrative

The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2018-10-15.Corrected h4 manufacture date: 2018-10-16.Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the spring arm rear 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's statement rear cover and metal dust cover were replaced and the spring arm was brought back to service.Additionally, getinge technician confirmed that the device had been damaged due to improper use and the customer had already been informed how to handle it properly.It was established that when the event occurred, the surgical light did not meet its specification due to missing covers, which contributed to the event.Provided information do not indicate if upon the event occurrence the device was being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of missing spring arm¿s components on powerled ii range occurrence is moderate.As stated by subject matter expert at manufacturing site, the described event happened due to an inappropriate use.In order to prevent damages, operating manual includes instructions to pre-position arms prior to use.What is more, users are requested to pay attention to cracks in plastic parts.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 reference number (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: 13705429
• MDR Text Key: 287207468
• Report Number: 9710055-2022-00073
• Device Sequence Number: 1
• Product Code: FTD
• 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
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD567912923
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1