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

Model Number ARD568370953

Device Problem Leak/Splash (1354)

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

Event Date 11/26/2023

Event Type  malfunction  

Manufacturer Narrative

Event site name: event site city: additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 26th november, 2023 getinge became aware of an issue with one of surgical lights - hled.It was stated there are oil droplets under the stainless steel dust cover of the spring arm, with the risk of dripping off.We decided to report the issue in abundance of caution as any liquid falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

The correction of h3a device evaluated by mfg, h3b device not eval provide code and h3c if other provide code-explain deems required.This is based on the internal evaluation.Previous h3a device evaluated by mfg: no.Corrected h3a device evaluated by mfg: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: none.Previous h3c device not eval provide code: device not returned to manufacturer.Corrected h3c device not eval provide code: none.Getinge became aware of an issue with one of surgical lights - hled.It was stated there are oil droplets under the stainless steel dust cover of the spring arm, with the risk of dripping off.We decided to report the issue in abundance of caution as any liquid falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification due to oil leakage from hled surgical light, which contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.During the investigation, it was found that in the past the reported scenario has never led to serious injury nor death.Comparing the number of involved devices to the install base, we conclude that the failure ratio for the allegation of liquid leakage is low.As stated by the subject matter expert at the manufacturer¿s site, during the assembly of spring arms the supplier applies a creamed grease.Such creamed grease is turning into liquid only above 135°c.So, the black dripping liquid observed, therefore, cannot come from the spring arm itself but finds its origin elsewhere.The first likely cause is a combination of air conditioning and an excess of oil at the bushing location between the spring arm and the main arm.And according to the latest technical investigations carried out in august 2020 at maquet sas the second probable root cause would be an excess of cleaning product in the lower part of the spring arm, applied in spray or with a sponge, but not in compliance with the recommendations given in our user manual.Manufacturer¿s recommends following cleaning protocol described in user manual (hled um 01601en08_extract, pages 34-35).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's reference number: (b)(4).

• Brand Name: HLED
• 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: 18382695
• MDR Text Key: 331192094
• Report Number: 9710055-2023-00982
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568370953
• Device Catalogue Number: ARD568370953
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1