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

Model Number ARDVCS209004A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 29th march, 2021 getinge became aware of an issue with one of surgical lights - volista access.The dust cover of the spring arm fell off.We are not aware of any injury this has caused however we decided to report the issue based on the potential as detachment of any component may cause risk of contamination of sterile field.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - volista access.The dust cover of the spring arm fell off.We are not aware of any injury this has caused however, we decided to report the issue based on the potential as detachment of any component may cause risk of contamination of sterile field.It was established that when the event occurred, the surgical light did not meet its specification as dust cover should not detach - and therefore it contributed to incident.There is no indication that at the time when the event occurred, the device was being used for patient treatment or diagnosis.The manufacturer¿s subject matter experts have investigated the issue.The possible root causes of the issue with dust covers are: non-conformity of the metal covers¿ assembly.Degradation of the metal covers.Improper use (collision with another device) according to technician who was at site the issue occurred due to device misuse by the customer.In the scope of our continuous improvement policy, maquet sas initiated a modification file to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe that if the manufacturer recommendation would have been followed the incident would have been avoided.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 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: 11731956
• MDR Text Key: 247564391
• Report Number: 9710055-2021-00146
• 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
• Report Date: 05/20/2021

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 Operator: No Information
• Device Model Number: ARDVCS209004A
• Device Catalogue Number: ARDVCS209004A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/20/2021
• Patient Sequence Number: 1