MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LAMP, SURGICAL

Model Number ARDLCA219001A

Device Problem Corroded (1131)

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.Device not returned to manufacturer.

Event Description

On 24th of may 2021 getinge became aware of an issue with one of our surgical lights - lucea 100.Screws developed rust occurrence, what was confirmed by a photographic evidence.No information about any injury has been provided however we decided to report this case in abundance of caution as any rust particles falling into sterile field might led to contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue regarding one of surgical lights - lucea 100.As it was stated, screws developed rust occurrence.There was no injury reported, however, based on the initial allegation it could not be ruled out that a part might have fallen off the device.Therefore, we decided to report the issue in abundance of caution as any rust particles falling into sterile field or during surgery might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification, due to metal part broken off the swivel arm and it contributed to event.It was not established if in the time when the event occurred the device was or was not being used for the patient treatment.During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse.Manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the part involved and the root cause.In case of new relevant information, the case will be reconsidered.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

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

• Brand Name: LUCEA 100
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11907048
• MDR Text Key: 255458852
• Report Number: 9710055-2021-00209
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDLCA219001A
• Device Catalogue Number: ARDLCA219001A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/02/2021
• Patient Sequence Number: 1