MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP 600; LAMP, SURGICAL

Model Number ARD568821912

Device Problem Corroded (1131)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 16th june, 2022 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated the corrosion has built up on the device.We decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated the corrosion has built up on the device.We decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the device did not meet its specification, due to corrosion.It was not established if in the time when the event occurred the device was being used for the patient treatment.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a low ratio.Despite our best efforts, we did not receive sufficient information to conduct the technical investigation.It is not possible to determine the part involved and the root cause.In case of new relevant information, the case will be reconsidered.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 600
• 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: 14786900
• MDR Text Key: 294594511
• Report Number: 9710055-2022-00230
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568821912
• Device Catalogue Number: ARD568821912
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1