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

Model Number 568811900

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.(b)(4).

Event Description

On (b)(6) 2019 maquet (b)(4) became aware of an issue with one of surgical lights- volista.As it was stated, per the design of the device there should be three screws located on the bracket however the inlet for one screw was damaged and one screw inside the cupola was missing.There was no injury reported, however we decided to report this issue based on the potential as lack of screw may lead to detachment of the cupola which may lead to an adverse event.Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas became aware of an issue with surgical light volista device related to cracked bracket.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.At the time when the event occurred the device was not being used for the patient treatment.During the investigation it was found that the occurrence rate for the issue of the light head shaft breaking is low (total of 14 complaints in the last 5 years of daily use of a large number of similar devices).The investigation was performed by product specialists at the manufacturer.It was established that the root cause of this incident is that one of three screws and its lock washer is missing.The lack of marks on metal at the screw location is concrete evidence of that fact.This screw has been forgotten on the assembly line during manufacturing process.The control process has been reinforced since(b)(6)2016 and the check of the presence of these 3 screws is now required.To sum up, the issue occurrence is due to manufacturing-man error.The affected devices are now being updated during field safety corrective action msa-2018-001-iu.The device involved in the event was found to be in the scope of mentioned fsca and action was performed on (b)(6)2019 , therefore getinge does not propose any other action at this time.

Event Description

Manufacturer reference number: 2019-62324.

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8343991
• MDR Text Key: 137015133
• Report Number: 9710055-2019-00038
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K130513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/17/2019

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: 568811900
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 01/29/2019; 01/29/2019; 01/29/2019; 01/29/2019; 01/29/2019; 01/29/2019; 01/29/2019
• Supplement Dates FDA Received: 03/12/2019; 04/05/2019; 04/30/2019; 05/24/2019; 06/21/2019; 07/16/2019; 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other