MAUDE Adverse Event Report: MAQUET SAS POWERLED 700; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568371939

Device Problem Material Erosion (1214)

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

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

E1b event site name: (b)(6) medical ctr.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 31th january, 2024 getinge became aware of an issue with one of surgical lights - powerled 700.It was found that the stop function was no longer present, there was a possibility to over rotation of the light head past the stops.This issue is related to an unusual abrasion of the head screws, and therefore, can generate metal fillings.According to the additional input provided by getinge technician there was a suspicion that the light was forced by the operator past the stops.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: POWERLED 700
• 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: 18766994
• MDR Text Key: 336973042
• Report Number: 9710055-2024-00170
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1