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

Model Number ARD567812999

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/18/2024

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 18th february, 2024 getinge became aware of an issue with one of surgical lights - xten.It was stated the nut was missing.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Initial reporter was biomedical technician.The correction of b5 describe event and problem, h6 investigation findings, h6 investigation conclusions, h3a device evaluated by mfg, h3b device not eval provide code and h3c if other provide code-explain and deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 18th february, 2024 getinge became aware of an issue with one of surgical lights - xten.It was stated the nut was missing.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem:on 18th february, 2024 getinge became aware of an issue with one of surgical lights - xten.It was stated the nut was missing.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee on 5th march 2024 indicated the nut was in the dome, so there is no risk of any particles or parts falling from device.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as the missing part couldn't fall to the sterile field, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h3a device evaluated by mfg: no.Corrected h3a device evaluated by mfg: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: none.Previous h3c device not eval provide code: device not returned to manufacturer.Corrected h3c device not eval provide code: none.Previous h6 investigation findings: results pending completion of investigation||3233.Corrected h6 investigation findings: none.Previous h6 investigation conclusions: conclusion not yet available||11 corrected h6 investigation conclusions: cause traced to component failure||4307 / cause.Traced to user||19.Initial information provided was pointing the nut was missing.The issue is considered as safety related as any parts or 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 the nut is part located inside the dome, so there was no risk of any parts falling to the sterile field.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.

Event Description

On 18th february, 2024 getinge became aware of an issue with one of surgical lights - xten.It was stated the nut was missing.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee indicated the nut was in the dome, so there is no risk of any particles or parts falling from device.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as the missing part couldn't fall to the sterile field, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: XTEN
• 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: 18824998
• MDR Text Key: 337152510
• Report Number: 9710055-2024-00187
• 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
• Report Date: 03/04/2024

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: ARD567812999
• Device Catalogue Number: ARD567812999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/18/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1