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

Model Number ARD567910990

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Other text : device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of a customer allegation about paint chipping from the main arm of the surgical light ¿ volista ¿ and also rust appearing on the mentioned part.There was no injury reported however we decided to report the issue in abundance of caution as any paint particle falling into the sterile field might be a source of contamination.

Manufacturer Narrative

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

Event Description

Manufacturer reference number ot278308.

Manufacturer Narrative

Getinge became aware of an issue with a surgical light volista standop device.As it was stated, rust and paint chipping occurred on the main arms of the device.No information about any patient involvement has been provided, however we decided to report this case based on potential as any parts falling down into the surgical field might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Peeling paint and rust is indicated by our product experts to likely be caused by an incorrect operation handling for pretreatment, the improper protection after rust or incomplete drying after rust process, therefore by manufacturing mistake.The product volista standop user manual ifu 01781 en ed.07 includes an information to daily check the device for chipped paint.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could 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's reference number:(b)(4).

• 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: 9525200
• MDR Text Key: 179258136
• Report Number: 9710055-2019-00369
• 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: 03/10/2020

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: ARD567910990
• Device Catalogue Number: ARD567910990
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/31/2020; 03/09/2020
• Supplement Dates FDA Received: 02/25/2020; 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1