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

Catalog Number ARD568832962

Device Problem Peeled/Delaminated (1454)

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

Event Date 07/08/2022

Event Type  malfunction  

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.We decided to report the issue in abundance of caution as any 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.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date 10/24/2018.Corrected h4 manufacture date 10/25/2018.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

It appeared that the issue reported under manufacturer¿s reference number:(b)(4)(report number: 9710055-2022-00300) is a duplicate of the issue reported under manufacturer¿s reference number: (b)(4) report number: 9710055-2022-00301).Therefore, the issue is evaluated under manufacturer¿s reference number: (b)(4).

Event Description

Manufacturer reference number (b)(4).

• 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: 15082948
• MDR Text Key: 302958587
• Report Number: 9710055-2022-00300
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD568832962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 08/03/2022; 10/17/2022
• Supplement Dates FDA Received: 08/25/2022; 10/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1