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

Model Number ARD567910992

Device Problem Material Erosion (1214)

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

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2018 maquet (b)(4) became aware about an issue with one of the surgical lights- volista.As it was stated, the arm of the device was rusted and the paint was damaged.There was no injury reported and no indication of falling particles given.However, having in mind similar complaints received in the past we decided to report the issue in abundance of caution as such damage in the paint integrity can result in parts falling into the sterile field and might be a source of contamination.(b)(4).

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005.Getinge usa sales, llc, 45 barbour pond drive, wayne, nj 07470.Contact person: (b)(6).Maquet sas became aware of an incident with surgical light volista device.As it was stated, the arm of the device was rusted and the paint was damaged.There was no injury reported and no indication of falling particles given.However, having in mind similar complaints received in the past we decided to report the issue in abundance of caution as the issue could have cause some parts falling into the sterile field and consequently, might have become a source of contamination.During the investigation, it was found that the reported scenario has never lead, to date, to serious injury or worse.The problem was reviewed by our product specialists and it was concluded that damage in the paint integrity can result in a possibility for rust to start developing, especially with a higher humidity and/or water ingress.Due to this reason, the current user manual is stating the conditions for storage, transport and use that should be followed to ensure that the device remains within its specification and is safe for usage.With that, we can say that the rust occurred on the device most likely due to damage of the protective layer that enable a rust development, due to the environmental conditions typical for that region.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the issue.The information about the time when the event occurred was not provided, we do not know if the device was or was not being used for the patient treatment.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

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

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8243887
• MDR Text Key: 133211745
• Report Number: 9710055-2019-00004
• 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: Replace
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567910992
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other