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

Model Number ARD568803933

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 21st december, 2020, getinge became aware of an issue with volista standop surgical light.As it was stated, the camera fell off.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Event Description

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

Manufacturer Narrative

Getinge became aware of an incident with surgical light volista standop device.The initial allegation was pointing to the camera which is part of the device assembly, dropped onto the floor and stopped working.From this allegation it was concluded that the camera detached from the device and fell on the floor.This situation was assessed as a malfunction that requires reporting to the authority reporting.However, after further evaluation with the complaint¿s originator it has been suggested that a technician at the facility was holding the camera and it dropped on the floor and this caused the damage.The alleged detachment of the camera from the assembly was not confirmed.Detachment of the device could possibly lead to contamination, while dropping device from the technician¿s hands during repair/maintenance work is not classified as risk related, therefore with the information at hand we no longer consider this issue reportable.It was established that when the event occurred, the surgical light assembly did meet its specification and it contributed to the event.There is no information that at the time when the event occurred the device was being used for the patient treatment, from the information received it appears it likely was not.During the investigation it was found that the occurrence rate for this issue is low (1 complaint on volista surgical lights in the last 5 years of daily use of a large number of similar devices).The investigation was performed by the subject matter expert at the manufacturing site, who concluded that the issue at hand to be related to a human error, namely a part being dropped from the technician¿s hand during repair/maintenance - which consequently let to the camera being inoperative.We believe that overall these 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.

• 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: 11063603
• MDR Text Key: 223454001
• Report Number: 9710055-2020-00517
• 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: 02/01/2021

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: Health Professional
• Device Model Number: ARD568803933
• Device Catalogue Number: ARD568803933
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1