MAUDE Adverse Event Report: MAQUET SAS ANGENIEUX AX4; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD179600ML

Device Problems Break (1069); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - angenieux ax4.It was stated the plastic pivot of the fork was broken, some pieces came loose and fell off.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 or serious injury.

Event Description

On 4th january, 2024 getinge became aware of an issue with one of surgical lights - angenieux ax4.It was stated the plastic pivot of the fork was broken, some pieces came loose and fell off and that the device bearings were worn and broken.Photographic evidence indicated that bearing between fork and headlight was broken off and taped, it resulted in the headlight detaching from one side of the double fork and risk of missing particles, also the paint on the headlight was damaged with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts and particles falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 4th january, 2024 getinge became aware of an issue with one of surgical lights - angenieux ax4.It was stated the plastic pivot of the fork was broken, some pieces came loose and fell off.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 or serious injury.Corrected b5 describe event and problem: on 4th january, 2024 getinge became aware of an issue with one of surgical lights - angenieux ax4.It was stated the plastic pivot of the fork was broken, some pieces came loose and fell off and that the device bearings were worn and broken.Photographic evidence indicated that bearing between fork and headlight was broken off and taped, it resulted in the headlight detaching from one side of the double fork and risk of missing particles, also the paint on the headlight was damaged with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts and particles falling off into sterile field or during procedure may cause contamination or serious injury.

• Brand Name: ANGENIEUX AX4
• 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: 18534811
• MDR Text Key: 333169055
• Report Number: 9710055-2024-00052
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD179600ML
• Device Catalogue Number: ARD179600ML
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1