MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP 400; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568832963

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

On 6th february 2024 getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.As it was stated when placing the handle, it sometimes becomes poorly fitted/secure and falls.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

Event site name: (b)(6), additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 6th february 2024 getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.As it was stated when placing the handle, it sometimes becomes poorly fitted/secure and falls.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.Corrected b5 describe event and problem: on 6th february 2024 getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.As it was stated when placing the handle, it sometimes becomes poorly fitted/secure and falls.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.According to the additional information provided on 10th february by getinge technician, after contact with the customer iit was verified that the reported anomaly did not refer to getinge equipment.Initially provided information was pointing to the handle issue, which sometimes becomes poorly fitted/secure and falls, concerned with one of our surgical lights ¿ volista standop 400.The issue is considered as safety related as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.According to additional clarification provided by the getinge technician, the initial information was incorrect, an error was found in sending the order to getinge.It was determined that the issue investigated herein could not be considered as a getinge complaint because there was no indication that our getinge device was involved in this incident.Therefore, the scenario described in the record is considered as non-reportable.

Event Description

On 6th february 2024, getinge became aware of an issue with one of our surgical lights ¿ volista standop 400.As it was stated when placing the handle, it sometimes becomes poorly fitted/secure and falls.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.According to the additional information provided on 10th february by getinge technician, after contact with the customer iit was verified that the reported anomaly did not refer to getinge equipment.

• Brand Name: VOLISTA STANDOP 400
• 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: 18675290
• MDR Text Key: 335005843
• Report Number: 9710055-2024-00134
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 02/09/2024

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 Model Number: ARD568832963
• Device Catalogue Number: ARD568832963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1