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

Model Number ARD5688111910

Device Problems Crack (1135); Material Fragmentation (1261)

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

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are aware that this is past the 30 day deadline for reporting.The service unit forwarded the information to the manufacturer regarding the issue with a delay.We have reminded them to review fda reporting guidelines in order to prevent this from happening again.The issue is being investigated by manufacturing site.

Event Description

On 4th december, 2018 maquet (b)(4) became aware of an issue with one of surgical lights- volista.As it was stated, the problem with crack on the fork and paint chip occurred.There was no injury reported; however, we decided to report the issue based on the potential as any paint particle falling off into sterile field or during "prcedure" might be a source of contamination.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

(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.

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

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

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number; 2019-62151.

Manufacturer Narrative

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 STANDOP
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8271772
• MDR Text Key: 134211500
• Report Number: 9710055-2019-00019
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD5688111910
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other