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

Model Number ARDVST229019A

Device Problems Peeled/Delaminated (1454); No Apparent Adverse Event (3189)

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

Event Date 12/29/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6)2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was peeling from the device.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Event Description

On 29th december, 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was peeling from the device.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee indicated that the paint wasn't peeling from device.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

Manufacturer Narrative

The correction of b5 describe event and problem and d4 catalog # and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 29th december, 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was peeling from the device.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 b5 describe event and problem: on 29th december, 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was peeling from the device.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee indicated that the paint wasn't peeling from device.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous d4 catalog # ardvst229019a.Corrected d4 catalog # ard568811962/ard568812962.Previous h6 medical device ¿ problem code: material integrity problem|degraded|peeled/delaminated|1454.Corrected h6 medical device ¿ problem code: no apparent adverse event|||3189.Initially provided information was pointing to paint peeling.The issue is considered as safety related as any particles falling off into sterile field or during procedure may cause contamination.According to additional clarification provided by the getinge technician, the initial information was incorrect.It was determined that the issue investigated herein is not safety and risk related as there was no indication of paint damage on this device.Therefore, the scenario described in the record is considered as non-reportable.It was established that when the event occurred, the device was up to the manufacturer specification and was not being used for patient treatment or diagnosis.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

• Brand Name: VOLISTA STANDOP
• 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: 16136747
• MDR Text Key: 307686558
• Report Number: 9710055-2023-00024
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDVST229019A
• Device Catalogue Number: ARD568811962/ARD568812962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1