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

Model Number	ARDSAT209010A
Medical Device Problem Codes	Corroded (1131); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1h event site postal code: (b)(6).H3 other text : device not returned to manufacturer.
Event or Problem Description
On 9th november 2023 getinge became aware of an issue with one of our surgical lights ¿ volista standop.As it was stated, paint was chipping and corrosion has built up on the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint or rust 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.During the preventive maintenance the paint chip and corrosion issues were detected on the device.Based on photographic evidence the paint chipping and rust occurred on spring arm and main tube.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 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 device was not being used for a patient¿s treatment upon the event occurrence.According to information provided by the technician the issue was discovered during preventive maintenance.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 manufacturing site, the 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% (attachment 1 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 (attachment 1 nu ifu 01781 en 19, page 37).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 (attachment 1 nu ifu 01781 en 19, page 89).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 (attachment 1 nu ifu 01781 en 19, page 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.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 (attachment 3 nm 01780 en 03 extract ).Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.Initial reporter: getinge service technician.The correction of b5 describe event or problem, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 9th november 2023 getinge became aware of an issue with one of our surgical lights ¿ volista standop.As it was stated, paint was chipping and corrosion has built up on the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint or rust particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem: on 9th november, 2023 getinge became aware of an issue with one of surgical lights - volista standop.During the preventive maintenance the paint chip and corrosion issues were detected on the device.Based on photographic evidence the paint chipping and rust occurred on spring arm and main tube.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 in case of reoccurrence.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.
Event or Problem Description
On 9th november, 2023 getinge became aware of an issue with one of surgical lights - volista standop.During the preventive maintenance the paint chip and corrosion issues were detected on the device.Based on photographic evidence the paint chipping and rust occurred on spring arm and main tube.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 in case of reoccurrence.

• Brand Name: VOLISTA STANDOP
• Common Device Name: 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: 18138445
• Report Number: 9710055-2023-00879
• Device Sequence Number: 20450100
• Product Code: FSY
• UDI-Device Identifier: 03700712405410
• UDI-Public: (01)03700712405410
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/15/2023

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
• Operator of Device: Other
• Device Model Number: ARDSAT209010A
• Device Catalogue Number: ARDSAT209010A
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown