MAUDE Adverse Event Report: MAQUET SAS POWERLED II 700; LAMP, SURGICAL

Model Number ARD569201915

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On (b)(6), 2023 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the inner seal has pulled away from the corner allowing moisture into the light panels causing streaking and debris internally.Upon inspection of the light it was found that the issue is the hydrogen peroxide cleaner that is being used to clean the light.It is not an approve cleaning agent and has damaged the light seal integrity making it easier for the cleaning solution to enter the inside of the light, which is what is causing the streaking on the lens.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock and particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2019-06-25 corrected h4 manufacture date: 2019-06-26.It appeared that the issue reported under manufacturer¿s reference number: (b)(4)(report number: 9710055-2023-00797) is a duplicate of the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00638).Therefore, the issue is evaluated under manufacturer¿s reference number: ot870172 (report number: 9710055-2023-00638).

Event Description

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

• Brand Name: POWERLED II 700
• 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: 17984067
• MDR Text Key: 326244187
• Report Number: 9710055-2023-00797
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD569201915
• Device Catalogue Number: ARD569201915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1