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

Model Number ARD567510901

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

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

On 6th february 2024 getinge became aware of an issue with one of our surgical lights ¿ axcel.As it was stated, the underside cover was cracked and the sterilizable handle holder was broken.The getinge technician advised not to use the lamp due to the risk of particles falling into the operating field.There was no injury reported and the circumstances of the issue are unknown.However, considering the worse case scenario the missing particles could detach from the device and fall off into the sterile field, therefore we decided to report this issue in abundance of caution as it might be a source of contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 6th february 2024 getinge became aware of an issue with one of our surgical lights ¿ axcel.As it was stated, the underside cover was cracked and the sterilizable handle holder was broken.The getinge technician advised not to use the lamp due to the risk of particles falling into the operating field.There was no injury reported and the circumstances of the issue are unknown.However, considering the worse case scenario the missing particles could detach from the device and fall off into the sterile field, therefore we decided to report this issue in abundance of caution as it might be a source of contamination.Further information provided by getinge employee indicated that no particles were missing from the device.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 missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

Manufacturer Narrative

The biomedical department informed getinge about problem.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 6th february 2024 getinge became aware of an issue with one of our surgical lights ¿ axcel.As it was stated, the underside cover was cracked and the sterilizable handle holder was broken.The getinge technician advised not to use the lamp due to the risk of particles falling into the operating field.There was no injury reported and the circumstances of the issue are unknown.However, considering the worse case scenario the missing particles could detach from the device and fall off into the sterile field, therefore we decided to report this issue in abundance of caution as it might be a source of contamination.Corrected b5 describe event and problem: on 6th february 2024 getinge became aware of an issue with one of our surgical lights ¿ axcel.As it was stated, the underside cover was cracked and the sterilizable handle holder was broken.The getinge technician advised not to use the lamp due to the risk of particles falling into the operating field.There was no injury reported and the circumstances of the issue are unknown.However, considering the worse case scenario the missing particles could detach from the device and fall off into the sterile field, therefore we decided to report this issue in abundance of caution as it might be a source of contamination.Further information provided by getinge employee indicated that no particles were missing from the device.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 missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907 material integrity problem|crack||1135 corrected h6 medical device ¿ problem code: material integrity problem|crack||1135 previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: none initially provided information was pointing to the underside cover which was cracked and the sterilizable handle which was broken.The issue is considered as safety related as any particles falling off into sterile field or during procedure may cause contamination.According to additional clarification provided by the getinge technician, the initial information was incorrect.It was determined that the issue investigated herein is not safety and risk related as there was no indication of missing particles.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.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

• Brand Name: AXCEL
• 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: 18693437
• MDR Text Key: 335217162
• Report Number: 9710055-2024-00141
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD567510901
• Device Catalogue Number: ARD567510901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1