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

Model Number	ARDVST229002A
Medical Device Problem Codes	Corroded (1131); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2022 getinge became aware of an issue with one of surgical lights, volista standop.According to photographic evidence, the paint was peeling and rust occured on the suspension arm.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.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista standop.According to photographic evidence, the paint was peeling and rust occured on the suspension arm.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.According to the information provided by getinge technician, the repair is completed and functional tests carried out with positive results.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.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Event or Problem Description
Manufacturer reference number ot (b)(4).

• Brand Name: VOLISTA STANDOP
• Common Device Name: 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: 15445168
• Report Number: 9710055-2022-00376
• Device Sequence Number: 15331343
• Product Code: FTD
• UDI-Device Identifier: 03700712401764
• UDI-Public: (01)03700712401764
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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: ARDVST229002A
• Device Catalogue Number: ARDVST229002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown