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

Model Number ARDVCS209015A

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

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.Event site telephone: (b)(6).H3 other text : device not returned to manufacturer.

Event Description

On 9th november, 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated that corrosion and paint chip issues occured on the device.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 or serious injury.

Event Description

On 9th november, 2023 getinge became aware of an issue with one of surgical lights - volista access.During preventive maintenance it was noticed and confirmed by photographic evidence, the paint chip and corrosion built up on the satellite tube plates and fork of the surgical light assembly.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 in case of reoccurrence.

Manufacturer Narrative

The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem # on 9th november, 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated that corrosion and paint chip issues occured on the device.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 or serious injury.Corrected b5 describe event and problem # on 9th november, 2023 getinge became aware of an issue with one of surgical lights - volista access.During preventive maintenance it was noticed and confirmed by photographic evidence, the paint chip and corrosion built up on the satellite tube plates and fork of the surgical light assembly.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 in case of reoccurrence.Initial reporter was getinge service technician.During preventive maintenance it was noticed and confirmed by photographic evidence, the paint chip and corrosion built up on the satellite tube plates and fork of the surgical light assembly.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 in case of reoccurrence.According to information provided by the technician the issue probably occurred due to fumigation performed by a customer on the device.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification due to rust occurrence and paint peeling.Such a scenario could be considered as technical deficiency, and in this way the device contributed to the event.The provided information does indicate that upon the event occurrence, the device was not being used for patient treatment.The issue was discovered by getinge technician during a maintenance visit.When reviewing reportable events for this type of issues we were able to establish that the received incidents are occurring at a low (for the rust issue) and moderate (for the paint peeling issue) ratio.We have been able to confirm that the investigated issues have never led to serious injury or worse, to our knowledge.As stated by the subject matter expert at maquet sas, the obtained photographic evidence shows rust formation and paint peeling on the device.It can be observed that the degradation of the paint and corrosion are mostly localized on the retention areas which shows that the stagnation of liquid or cleaning agent residues have caused paint damages and appearance of rust.Peeling paint and rust formation were probably caused by: a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning protocol.The presence of liquid water or an exposure to humid air due to a high relative humidity of the operating room.The instruction for use indicates the environmental condition for use, the relative humidity must be between 20% and 75% (nu ifu 01781 en 19, page 29).To prevent any incident the instruction for use mentions to perform daily and monthly inspection in order to detect painting defects, impact marks or other damages (nu ifu 01781 en 19, pages 37, 93).The instruction for use mentions not to clean the device under running water nor spray a solution directly onto the device.Certain cleaning products or procedures may damage the paintwork of the device, which may result in particles falling onto the surgical site during an operation.Fumigation methods are unsuitable for disinfecting the unit and must not be used.The instruction for use mentions to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning (nu ifu 01781 en 19, pages 89-90).To reduce the appearance of rust or the degradation of the surface, the technical manual or maintenance manual mentions in the preventive maintenance protocol to lubricate some parts of device (nm 01780 en 03, page 51).The instruction for use mentions not to use a damaged device because it may lead to a risk of injury for users or a risk of infection for patients.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: VOLISTA ACCESS
• 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: 18138553
• MDR Text Key: 328113501
• Report Number: 9710055-2023-00880
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ARDVCS209015A
• Device Catalogue Number: ARDVCS209015A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1