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

Model Number ARD567825999

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 23rd march, 2021 getinge became aware of an issue with xten surgical light.As it was stated, plates for spring arm were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with xten surgical light.As it was stated, plates for spring arm were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event, as the dust covers should be attached still to the device.There is no information provided if in the time when the event occurred the device was or was not being used for the patient treatment.The possible root causes are: - non-conformity of the metal covers assembly.- degradation of the metal covers.- improper use (collision with another device) maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.

Event Description

Manufacturer's reference number (b)(4).

• 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
• MDR Report Key: 11567740
• MDR Text Key: 242210885
• Report Number: 9710055-2021-00112
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

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 Operator: No Information
• Device Model Number: ARD567825999
• Device Catalogue Number: ARD567825999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/20/2021
• Patient Sequence Number: 1