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

Model Number ARDVCS209004A

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with volista access surgical light.The paint peeling occurred on fork's keypad, what was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint 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 d4 model # and catalog # fields deem required.This is based on internal evaluation of available data.D4 model # previous: ardvcs209000a.Corrected: ardvcs209004a.D4 catalog # previous: ardvcs209000a.Corrected: ardvcs209004a.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with volista access surgical light.The paint peeling occurred on fork's keypad, what was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint 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 appearance of chipped paint could be considered as technical deficiency, and in this way device contributed to event.The provided information indicates that the device was not being used for patient treatment when the event took place.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¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow detecting the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.It is also recommended to avoid excessive friction during cleaning or inappropriate cleaning products.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: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11552971
• MDR Text Key: 242179089
• Report Number: 9710055-2021-00108
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDVCS209004A
• Device Catalogue Number: ARDVCS209004A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2021
• Patient Sequence Number: 1