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

Catalog Number ARD568821911

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/03/2021

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 one of surgical lights - volista standop.It was stated the keypad was detached from device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or injury.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - volista standop.It was stated the keypad was detached from the device.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or injury.Defective part was replaced and light was returned to use.It was established that when the event occurred, the device did not meet its specification, due to detachment keypad on the device and it contributed to event.It was not established if at 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.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a very low ratio.This incident is due to the debonding of the keypad pcb.The events are concentrated over a period of 6 months (from (b)(6) 2018 to (b)(6) 2018) that is to say products manufactured between august 2017 and march 2018, but is a probability to have this failure on units manufactured at a date close to this period.About this problem, the capa # 2018-15 (tw#(b)(4)) was inititated by maquet sas and despite investigation led both at maquet sas and at the supplier any cause could be confirmed.Nevertheless, at the end of 2018 the supplier has implemented some preventive actions to address the probable root causes.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

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

• 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
• 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: 13093332
• MDR Text Key: 282825269
• Report Number: 9710055-2021-00385
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD568821911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1