MAUDE Adverse Event Report: MAQUET SAS HANAULUX; LAMP, SURGICAL

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

On 6th june, 2023 getinge became aware of an issue with one of surgical lights - hanaulux.It was stated there were traces of sanitizer inside the lens glass due to excessive washing.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of sanitizer with live parts may cause electric shock.

Manufacturer Narrative

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

Manufacturer Narrative

The correction of b5 describe event and problem and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on (b)(6) 2023 getinge became aware of an issue with one of surgical lights - hanaulux.It was stated there were traces of sanitizer inside the lens glass due to excessive washing.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of sanitizer with live parts may cause electric shock.Corrected b5 describe event and problem: on (b)(6) 2023 getinge became aware of an issue with one of surgical lights - hanaulux.It was stated there were traces of sanitizer inside the lens glass due to excessive washing.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of sanitizer with live parts may cause electric shock.Further evaluation provided by subject matter expert indicated that there was low risk result, the potential risk is a reduced illumination, causing discomfort for the surgeon.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of possible risk of electric shock, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: none initially provided information was pointing to traces of sanitizer inside the lens glass due to excessive washing.The issue was considered as safety related as contact of sanitizer with live parts may cause electric shock.Based on evaluation provided by subject matter expert, it was determined that the issue investigated herein is not safety and risk related as there was no indication of possible risk of electric shock on this device.The investigation was performed.The investigated scenarios did not cause risk to human life.The review of the customer product complaints, related to investigated issue in time, shows that there is no regular income.There is no indication if the device was being used for patient treatment at the time when the event occurred.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - hanaulux.It was stated there were traces of sanitizer inside the lens glass due to excessive washing.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of sanitizer with live parts may cause electric shock.Further evaluation provided by subject matter expert indicated that there was low risk result, the potential risk is a reduced illumination, causing discomfort for the surgeon.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of risk of electric shock, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: HANAULUX
• Type of Device: LAMP, SURGICAL
• 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: 18204413
• MDR Text Key: 328900532
• Report Number: 9710055-2023-00916
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1