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

Model Number ARDVCS209007A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 getinge became aware of an issue with volista access surgical light.As it was stated, there was abnormal sound in dome.During technician intervention it appeared that connection between fork and light head was loose.There was no injury reported, however, taking into consideration worst case scenario which is detachment of the cupola, the issue may lead to serious injury or worse.

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with volista access surgical light.As it was stated, there was abnormal sound coming from the light dome.During technician intervention it appeared that connection between fork and light head was loose.There was no injury reported, however, taking into consideration worst case scenario which is detachment of the cupola, the issue may lead to serious injury or worse.It was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification as there was abnormal sound in dome and connection between fork and light head was loose and it contributed to the event.The investigated issue was discovered during preventive maintenance, therefore the device was not being used for patient treatment when the event took place.After reviewing the information provided for the customer product complaints investigated here, the complaint ratio for the issue with abnormal sound coming from the dome and loose screws and/or loose connection between fork and headlight or other arms is increasing.However we can assume that the complaint rate is low (b)(4).Due to the limited information available, the subject matter experts from the manufacturing site were not able to define an actual root cause of the situation occurrence.We believe the related devices are performing correctly in the market.

• 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: 11064899
• MDR Text Key: 223456566
• Report Number: 9710055-2020-00523
• 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: 10/22/2021

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: ARDVCS209007A
• Device Catalogue Number: ARDVCS209007A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 09/29/2021
• Supplement Dates FDA Received: 01/29/2021; 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1