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  

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

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

Event Description

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

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.According to the information provided by getinge technician, quote for repair of the affected device was sent to the customer and is currently pending his approval.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since appearance of corrosion could be considered as technical deficiency, and in this way devices contributed to event.It remains unknown whether the affected device was or was not being used for patient treatment or diagnosis when the event occurred.When reviewing reportable events for this type of issues we were able to establish that the received incidents are occurring at a low ratio.As stated by the subject matter expert at manufacturing site, maquet did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause and therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• 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: 14787443
• MDR Text Key: 294588780
• Report Number: 9710055-2022-00232
• 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: 08/17/2022
• 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