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

Catalog Number ARD568811960

Device Problem Crack (1135)

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

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 maquet sas became aware of an issue with one of the surgical lights- volista.As it was stated, there was a crack on the fork of the device which might lead to paint particles falling off.There was no injury reported, however it was decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure might be a source of contamination.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).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device (b)(6) exemption # e2018005.(b)(6).Contact person: (b)(6).Maquet sas became aware of a customer¿s problem with the volista device.As it was stated by the technician, there were cracks in the paint observed, specifically at the arc of the fork.There was no injury to a patient reported, however it was decided to report this issue based on the potential and in abundance of caution, as any particle falling from the device into the sterile field might be a source of contamination.When reviewing similar reportable events registered for volista surgical light we were able to find several similar issues compared to the problem investigated herein.In none of the complaints a serious injury or death occurred.Based on the information collected to date it was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification.The most probable root cause that the cracks appear was the detachment of the bonded parts of fork.It was established that the cracks were located only on the outer coating and there was no impact to the internal structure of the fork assembly.The breaks on the coating correspond to the excessive gap between two mechanical parts under the outer material.We have no information regarding the exact time when the defect first appeared or if it was being used for patient treatment in the time when the event occurred.A corrective/preventive action investigation into the issue has revealed that the issue may be the result of several factors, summarized as issues with the previous understanding of post-gluing aspects.A design change improved the assembling methods from glue-bonding to welding of the parts in production, since beginning of 2017.In addition, the device was included in the scope of field action msa-2019-001-iu and it was decided that the defective part will be replaced, therefore getinge does not propose any other action at this time.

• Brand Name: VOLISTA
• 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: 8518569
• MDR Text Key: 145753279
• Report Number: 9710055-2019-00143
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ARD568811960
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1