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

Model Number ARD568231210C

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6)2022.Getinge became aware of an issue with one of our surgical lights ¿ xten.As it was stated, paint was chipping from spring arms.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.

Manufacturer Narrative

The correction of d4 catalog # and d4 serial # deems required.This is based on the internal evaluation.Previous d4 catalog # ard568231210c.Corrected d4 catalog # ard567813999/ard567814999.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Getinge became aware of an issue with one of our surgical lights ¿ xten.As it was stated, paint was chipping from spring arms.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.A quote for repair was sent to the customer, however, according to the information provided by getinge technician it might have not been accepted as the customer had been getting surveyed for the replacement of the affected surgical light.It was established that when the event occurred, the surgical light did not meet its specification due to the occurrence of paint chipping which contributed to the event.There is no information if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing similar reportable events in the last 5 years it was confirmed that none of the reported scenario on xten surgical lights has lead to serious injury or worse.As stated by subject matter experts at maquet sas, all their products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages (xten user manual 0130103 3a, pages 17-21).To prevent any similar incident, it is recommended to avoid the collisions between devices (xten user manual 0130103 3a, page 17).Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

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
• 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: 16076785
• MDR Text Key: 306409128
• Report Number: 9710055-2022-00567
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568231210C
• Device Catalogue Number: ARD567813999/ARD567814999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1