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

Model Number ARDVST229038A

Device Problem Corroded (1131)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Ice not returned to manufacturer.

Event Description

On 26th january, 2021 getinge became aware of an issue with volista access surgical light.The rust has been detected on the spring arm.There was no injury reported, however, we decided to report the event in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.

Event Description

On 26th january, 2021 getinge became aware of an issue with volista standop surgical light.The rust has been detected on the spring arm.There was no injury reported, however, we decided to report the event in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of b5.Describe event or problem, d4 model #, catalog # and serial # sections deem required.This is based on the information provided by a service unit.Previous d4: model # ard568805905.Catalog # ard568805905.Serial # (b)(6).Corrected d4: model # ardvst229038a.Catalog # ardvst229038a.Serial # (b)(6).B5.Describe event or problem previous: on 26th january, 2021 getinge became aware of an issue with volista access surgical light.The rust has been detected on the spring arm.There was no injury reported, however, we decided to report the event in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.Corrected: on 26th january, 2021 getinge became aware of an issue with volista standop surgical light.The rust has been detected on the spring arm.There was no injury reported, however, we decided to report the event in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

On 26th of january, 2021 getinge became aware of an issue with one of surgical lights - volista vst64sf standop.The unit with catalogue number ardvst229038a, serial number (b)(6) and udi: applicable to the configuration vst64sf : (b)(4) was manufactured on 21st october 2016.As it was state, the rust occurred on the mentioned device.There was no injury reported however, we decided to report the issue based on the potential as any particles fell off into sterile field may cause contamination.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Based on the information collected to date it was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification as corrosion appears on the device and it could be treated as technical deficiency and in this way the device contributed to event.We have not received information whether the device was being used for patient treatment at the time when the event took place.As it was established by our subject matter experts the concentration of chemical products and the stagnation of cleaning agent residues on the disinfected surfaces are the main factors leading to the deterioration of surfaces.To avoid paint degradation and corrosion it is recommended to respect the cleaning instructions (see user manuals ifu 01581/01601 and ifu volista 01781), avoiding spraying, high concentrations, prolonged exposure to detergents / disinfectants solutions, and to wipe with a dry cloth and to make sure that 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 01582/01602 mentions in the preventive maintenance to lubricate some parts of device.To prevent any incident the user manuals ifu 01581/01601 and ifu volita 01781 mention to perform daily inspections in order to detect paint defects, impact marks or other damages.It is recommended to perform corrective maintenance to rectify the default after its detection.Minor paint chips can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.We believe that all remaining devices are performing correctly in the market.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer's reference number (b)(4).

• 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
• MDR Report Key: 11250367
• MDR Text Key: 229592328
• Report Number: 9710055-2021-00032
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDVST229038A
• Device Catalogue Number: ARDVST229038A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1