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

Model Number ARD568832962

Device Problem Material Erosion (1214)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with volista standop surgical light.The spring arm's metal dust cover was incorrectly placed, what resulted in damaging the plastic cover, leading to fall of plastic shavings.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off may lead to contamination.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with volista standop surgical light.The spring arm's metal dust cover was incorrectly placed, what resulted in damaging the plastic cover, leading to fall of plastic shavings.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.It was not established if in the time when the event occurred the device was or was not being used for the patient treatment.During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse.It was noted that the metal strings cannot move out of the spring arm if they are fitted correctly.The two plastic covers snap together with plastic hooks and can be separated only with the use of a tool.File (e131106) explain in the technical documentation how to fit correctly the metal strips on the spring arm.If correct assembly is impossible.Manufacturer recommends to order new covers and metal strips.The possible root causes are : - non-conformity of the metal covers assembly.- degradation of the metal covers.- improper use (collision with another device).Maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Manufacturer Narrative

The purpose of this submission is solely to provide a correction of describe event or problem section this is based on the information provided by the service unit.#b5: previous describe event or problem: on 18th may, 2021 getinge became aware of an issue with volista standop surgical light.The spring arm's metal dust cover was incorrectly placed, what resulted in damaging the plastic cover, leading to fall of plastic shavings.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off may lead to contamination.Corrected describe event or problem: on 18th may, 2021 getinge became aware of an issue with one of surgical lights - volista standop.Initially claimed issue was not considered as safety related.However, during visit to perform examination in customer¿s facility on 24th may 2021 it was detected that the spring arm's metal dust cover was incorrectly placed, what resulted in damaging the plastic cover, leading to fall of plastic shavings.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off may lead to contamination.

Event Description

On 18th may, 2021 getinge became aware of an issue with one of surgical lights - volista standop.Initially claimed issue was not considered as safety related.However, during visit to perform examination in customer¿s facility on 24th may 2021 it was detected that the spring arm's metal dust cover was incorrectly placed, what resulted in damaging the plastic cover, leading to fall of plastic shavings.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off may lead to contamination.

Manufacturer Narrative

The purpose of the report is solely to provide correction of b5.Describe event or problem field.This is based on the additional clarification provided by the service unit.Previous b5.Describe event or problem: on 18th may, 2021 getinge became aware of an issue with one of surgical lights - volista standop.Initially claimed issue was not considered as safety related.However, during visit to perform examination in customer¿s facility on 24th may 2021 it was detected that the spring arm's metal dust cover was incorrectly placed, what resulted in damaging the plastic cover, leading to fall of plastic shavings.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off may lead to contamination.Corrected b5.Describe event or problem: on 18th may, 2021 getinge became aware of an issue with one of surgical lights - volista standop.Initially claimed issue was not considered as safety related.However, during visit to perform the repair in customer¿s facility on 16th june 2021 it was detected that the spring arm's metal dust cover was incorrectly placed, what resulted in damaging the plastic cover, leading to fall of plastic shavings.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off may lead to contamination.

Event Description

On 18th may, 2021 getinge became aware of an issue with one of surgical lights - volista standop.Initially claimed issue was not considered as safety related.However, during visit to perform the repair in customer¿s facility on 16th june 2021 it was detected that the spring arm's metal dust cover was incorrectly placed, what resulted in damaging the plastic cover, leading to fall of plastic shavings.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off may lead to contamination.

• 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: 12056746
• MDR Text Key: 258023744
• Report Number: 9710055-2021-00232
• 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,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568832962
• Device Catalogue Number: ARD568832962
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/17/2021
• Patient Sequence Number: 1