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

Model Number ARD568812910

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

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

Event Date 09/21/2023

Event Type  malfunction  

Event Description

On 21st september 2023, getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.As it was stated, the paint was damaged and the corrosion occurred on the arm.The designated complaint unit employee confirmed based on photographic evidence that the paint was peeling and the corrosion has built up on the spring arm.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 in case of reoccurrence.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Initial reporter: getinge service technician h3 other text : device not returned to manufacturer.

Event Description

On 21st september 2023 getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.The received customer allegation regarded a non-reportable issue.Further information became available on 23rd february 2024 following the inspection visit at the customer site.As it was stated, the paint was damaged and the corrosion occurred on the arm.The designated complaint unit employee confirmed based on photographic evidence that the paint was peeling and the corrosion has built up on the spring arm.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 in case of reoccurrence.

Manufacturer Narrative

Initial reporter was getinge technician.The correction of b5 describe event and problem, h3a device evaluated by mfg, h3b device not eval provide code and h3c if other provide code-explain deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 21st september 2023, getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.As it was stated, the paint was damaged and the corrosion occurred on the arm.The designated complaint unit employee confirmed based on photographic evidence that the paint was peeling and the corrosion has built up on the spring arm.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 in case of reoccurrence.Corrected b5 describe event and problem: on 21st september 2023 getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.The received customer allegation regarded a non-reportable issue.Further information became available on 23rd february 2024 following the inspection visit at the customer site.As it was stated, the paint was damaged and the corrosion occurred on the arm.The designated complaint unit employee confirmed based on photographic evidence that the paint was peeling and the corrosion has built up on the spring arm.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 in case of reoccurrence.Previous h3a device evaluated by mfg: no corrected h3a device evaluated by mfg: yes previous h3b device not eval provide code: other corrected h3b device not eval provide code: none previous h3c device not eval provide code: device not returned to manufacturer corrected h3c device not eval provide code: none 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/or 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 as stated by the subject matter expert, peeling paint and/or 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%.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.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.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.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: VOLISTA STANDOP
• 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: 18825556
• MDR Text Key: 336760519
• Report Number: 9710055-2024-00188
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 03/04/2024

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: ARD568812910
• Device Catalogue Number: ARD568812910
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1