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

Catalog Number ARD569201915

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/10/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of surgical lights - powerled ii. The screw fell off the arm. There was no injury reported however we decided to report the issue basing on potential as any parts falling off into sterile field or during procedure may be a source of contamination.

Manufacturer Narrative

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

• 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: 13009612
• MDR Text Key: 282268785
• Report Number: 9710055-2021-00374
• 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

• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD569201915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse