MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP 400 / 600; LAMP, SURGICAL

Model Number ARD568812910 / ARD568811910

Device Problems Corroded (1131); Peeled/Delaminated (1454)

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

Event Date 04/05/2022

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 surgical lights - volista standop.Corrosion has built up on the device and the paint was peeling.We decided to report the issue in abundance of caution as any rust or paint particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

The correction of d4 serial# deems required.This is based on the internal evaluation.Previous d4 serial#: (b)(6)/ (b)(6).Corrected d4 serial#: (b)(6)/ (b)(6).Getinge became aware of issues with surgical light - volista standop.Corrosion has built up on the devices and the paint was peeling.We decided to report the issue in abundance of caution as any rust or paint particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since rust occurrence and paint chipping could be considered as technical deficiencies, and in this way the device contributed to event.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.When reviewing reportable events for this type of issues we were able to establish that the received incidents are occurring at a low ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.According to subject matter expert at manufacturer¿s, the most probable root cause of this premature oxidation and paint degradation would be an incorrect operation handling before painting.The pre-treatment operation could be involved.The improper protection after rust or incompletely dry after rust process would have led to the containment and oxidization under the paint.So far, all the cases reported correspond to main arms manufactured before july 2016, hence by the supplier fengmi.The painting suppliers have changed since july 2016.The current one is huaya who has strengthened the process and parameters stability.No cases have been reported since the supplier fengmi has been replaced.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.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 reference number (b)(4).

• Brand Name: VOLISTA STANDOP 400 / 600
• Type of Device: LAMP, SURGICAL
• 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: 14083475
• MDR Text Key: 289079095
• Report Number: 9710055-2022-00116
• Device Sequence Number: 1
• Product Code: FTD
• 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: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568812910 / ARD568811910
• Device Catalogue Number: ARD568812910 / ARD568811910
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1