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

Model Number VCS64SF - ARDVCS209006A

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

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of surgical lights, volista access.As getinge was informed, the rust occurred on the device and the paint was chipping off from surgical light.It was confirmed by the photographic evidence.We decided to report the issue in abundance of caution as any 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.H3 other text : device not returned to manufacturer.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - volista access.As getinge was informed, the rust occurred on the device and the paint was chipping off from surgical light.It was confirmed by the photographic evidence.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.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, since paint peeling and rust could be considered as technical deficiency, and in this way device contributed to event.There is information that the device was not being used for patient treatment when the event took place.Comparing the number of devices installed on the market to the number of complaint it can be concluded that occurrence rate is low.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 ¿ general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.This even is clearly due to cleaning product.Nevertheless, the deterioration of this paint is far advanced and it must have started years ago.Such troubles should have been detected first by the user during daily and monthly checks.The current cleaning product must be improved as described in the user manual.The damaged parts must be replaced as soon as possible.We believe that remaining devices are performing correctly in the market.Given the circumstances and the fact that there is no apparent trend in complaints of this nature 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 ACCESS
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 12524645
• MDR Text Key: 273075364
• Report Number: 9710055-2021-00307
• Device Sequence Number: 1
• Product Code: FTD
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VCS64SF - ARDVCS209006A
• Device Catalogue Number: ARDVCS209006A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2021
• Patient Sequence Number: 1