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

Model Number ARD568821961

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

On 23rd january 2024 getinge became aware of an issue with one of our surgical lights ¿ volista standop 600.As it was stated, upon the preventive maintenance activities being performed on the device, dust cover and spring arm side screws were found to be missing from the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Initial reporter: getinge service technician.E1b event site name: (b)(6).E1h event site postal code: (b)(6).H3 other text : device not returned to manufacturer.

• 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: 18585787
• MDR Text Key: 333780306
• Report Number: 9710055-2024-00090
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 01/26/2024

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 Operator: Other
• Device Model Number: ARD568821961
• Device Catalogue Number: ARD568821961
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1