MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS 400; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARDVCS209001A

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

On 15th june, 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access 400.As it was stated and confirmed with the photographic evidence, the headlight's underside cover was cracked with missing particles and headlight's seal was cracked with risk of missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6).H3: device was not returned to the manufacturer.

Event Description

On 15th june, 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access 400.As it was stated and confirmed with the photographic evidence, the headlight's underside cover was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Describe event and problem: on 15th june, 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access 400.As it was stated and confirmed with the photographic evidence, the headlight's underside cover was cracked with missing particles and headlight's seal was cracked with risk of missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected describe event and problem: on 15th june, 2023 getinge became aware of an issue with one of our surgical lights ¿ volista access 400.As it was stated and confirmed with the photographic evidence, the headlight's underside cover was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Previous d4 serial # (b)(6) corrected d4 serial # (b)(6) previous h4 manufacture date: 04/17/2019.Corrected h4 manufacture date: 04/21/2017.Getinge became aware of an issue with one of our surgical lights ¿ volista access 400.As it was stated and confirmed with the photographic evidence, the headlight's underside cover was cracked with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since the cracked underside cover could be considered as technical deficiency, and in this way the device contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing reportable events for this type of issues we were able to establish that the received incidents of cracked covers on volista surgical lights occur at a very low ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As stated by the subject matter expert at maquet sas, the crack, starting at the edge of the underside fixing point located under the peripheral seal, was caused by a collisions or an inadapted cleaning protocol.The underside fixing point located under the peripheral seal is a retention zone, residues of cleaning agent can lead, by stagnation, to a loss of mechanical properties of plastic parts.During the design and the development, of the volista light head, several cleaning tests were carried out, the conclusion of the report cre 15-030 states that no damage was observed to prevent any incident during the surgical procedure, the volista instruction for use ifu 01781 en19 mentions: to perform daily inspections checking that the underside is not damaged (page 39).The risk of collision and explains to pre position the device to avoid it (pages 60-64).How to clean and disinfect the light heads.This document includes some recommended products and some prohibited products (pages 89-90).The volista light head must be used according to the instructions for use.To prevent any degradation it is recommended to avoid collisions and to wipe the surfaces with a dry cloth to make sure that no liquid residue is left on the device after cleaning.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any action at this time.

• Brand Name: VOLISTA ACCESS 400
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 17189757
• MDR Text Key: 317733433
• Report Number: 9710055-2023-00464
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 03700712401290
• UDI-Public: 03700712401290
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDVCS209001A
• Device Catalogue Number: ARDVCS209001A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1