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

Model Number ARD568821962

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/10/2021

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 the surgical lights - volista. It was stated that during surgery paint was peeling from fork and fell into sterile field. We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.

• 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: 13150546
• Report Number: 9710055-2022-00003
• Device Sequence Number: 1
• Product Code: FTD
• 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

• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568821962
• Device Catalogue Number: ARD56821962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1308-2022
• Patient Sex: No Answer Provided
• Patient Weight: KG