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

Catalog Number ARD567812999

Device Problems Corroded (1131); Material Erosion (1214)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

On 24th january 2023 getinge became aware of an issue with one of surgical lights - xten.Initially claimed issue was not considered as safety related, however, during the inspection performed by the getinge technician on 24th february 2023 it was revealed that the rust build up on the device and the suspension arm connection was seized creating the risk of falling particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

The initial reporter was a biomedical department employee.Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

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

Manufacturer Narrative

The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2007-02-01.Corrected h4 manufacture date: 2007-02-16.Getinge became aware of an issue with one of surgical lights - xten.Initially the issue, as received, was not considered as safety related.However, during the inspection performed by a getinge technician on 24th february 2023, it was revealed that the rust build-up on the device and the suspension arm connection, had seized, creating the risk of particles falling in the procedure zone.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected to date it was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification, since rust and oxidation could be considered as a malfunction, and in this way device contributed to event.There is no information that the device was or was not being used for patient treatment when the event took place.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.A root cause was analyzed by subject matter experts at manufacturing site.As stated, the most probable root cause of this incident are: higher humidity in the operating room.Water ingress.Fumigation treatment (not approved by maquet sas).The user manual mentions all the recommendations about the environmental conditions for use (ifu for xten 0130103 3a, page 24).The user manual explains how to check the devices during daily inspection (ifu for xten 0130103 3a, page 26).Maquet sas recommends to inform the customers about the hazards in cases of non-compliance of these instructions.Additionally, taking into account information provided by getinge technician, the last maintenance was performed in 2018.Because of this lack of maintenance combined with oxidation, the brakes had seized.We believe that if the manufacturer recommendation had been followed the incident could have been avoided.

• Brand Name: XTEN
• 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: 16512454
• MDR Text Key: 311110020
• Report Number: 9710055-2023-00201
• Device Sequence Number: 1
• Product Code: FSY
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD567812999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1