MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LIGHT, SURGICAL, FLOOR STANDING

Model Number ARD568604999

Device Problems Crack (1135); Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 14th march 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated and confirmed with photographic evidence, the cover was cracked with missing particles.There was no injury reported, however, 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 correction of b5 describe event or problem and h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 14th march 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated and confirmed with photographic evidence, the cover was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem: on 14th march 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated and confirmed with photographic evidence, the cover was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Upon further clarification, it has been established that the provided photographic evidence regarded different device and the issue was already reported under manufacturer¿s reference number: (b)(6) (report number: 9710055-2023-00212).Based on additional input from getinge employee, it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: material integrity problem|break|fracture|1260.Mechanical problem|detachment of device or device component||2907.Corrected h6 medical device ¿ problem code: material integrity problem|crack||1135.

Event Description

On 14th march 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated and confirmed with photographic evidence, the cover was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Upon further clarification, it has been established that the provided photographic evidence regarded different device and the issue was already reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00212).Based on additional input from getinge employee, it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: LUCEA 50
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• 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: 16700051
• MDR Text Key: 312870007
• Report Number: 9710055-2023-00299
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568604999
• Device Catalogue Number: ARD568604999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1