MAUDE Adverse Event Report: MAQUET SAS VOLISTA; LAMP, SURGICAL

Model Number ARD567701907

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/11/2022

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) 2022 getinge became aware of an issue with one of surgical lights- volista, to which x-ray shield mavig is connected.The covers fell off from spring arms due to impact between ceiling hangers.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2018-05-29.Corrected h4 manufacture date: 2018-05-30.Getinge became aware of an issue with one of surgical lights - volista, on which x-ray shield mavig is assembled.The covers fell off from spring arms due to impact between ceiling hangers.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Based on the provided information, casing and metal plate were installed on the device and the equipment was ultimately released for use after technician¿s intervention.It was established that when the event occurred, the surgical light did not meet its specification due to missing covers from x-ray shield mavig, an integral part of volista surgical light, which contributed to the event.Provided information indicate that upon the event occurrence, the device was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of missing covers or their particles on volista range occurrence is very low.As stated by subject matter expert at manufacturer¿s, the described event happened due to an inappropriate use.In order to prevent damages, operating manual includes instructions to pre-position arms prior to use.What is more, users are requested to pay attention to cracks in plastic parts.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: VOLISTA
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 13598857
• MDR Text Key: 286117695
• Report Number: 9710055-2022-00069
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD567701907
• Device Catalogue Number: ARD567701907
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1