MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP 600; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD368818998

Device Problem Corroded (1131)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

E1b event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated the arms were rusted.There was no injury reported, however, 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

The correction of b5 describe event and problem, h3b device not eval provide code, h6 medical device ¿ problem code, h6 investigation findings, h6 medical device ¿ component codes and h6 investigation conclusions fields deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 18th march, 2024 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated the arms were rusted.There was no injury reported, however, 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.Corrected b5 describe event and problem: on 18th march, 2024 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated the arms were rusted.There was no injury reported, however, 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.Further clarification provided by getinge employee indicated that initial information was incorrect, no rust was found on the device.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h3b device not eval provide code: device evaluation anticipated, but not yet begun corrected h3b device not eval provide code: blank previous h6 medical device ¿ problem code: material integrity problem|degraded|corroded|1131 corrected h6 medical device ¿ problem code: no apparent adverse event|||3189 previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: no device problem found|||213 previous h6 medical device ¿ component codes: mechanical|coating material||4768 corrected h6 medical device ¿ component codes: none previous h6 investigation conclusions: conclusion not yet available||11 corrected h6 investigation conclusions: no problem detected||67 initially provided information was pointing to rust on the device.The issue is considered as safety related as any rust particles falling off into sterile field or during procedure may cause contamination.According to additional clarification provided by the getinge technician, the initial information was incorrect.It was determined that the issue investigated herein is not safety and risk related as there was no indication of rust on this device.The investigation was performed.The investigated scenarios did not cause risk to human life.The review of the customer product complaints, related to investigated issue in time, shows that there is no regular income.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

Event Description

On 18th march, 2024 getinge became aware of an issue with one of surgical lights - volista standop 600.It was stated the arms were rusted.There was no injury reported, however, 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.Further clarification provided by getinge employee indicated that initial information was incorrect, no rust was found on the device.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: VOLISTA STANDOP 600
• 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: 18947878
• MDR Text Key: 338367121
• Report Number: 9710055-2024-00223
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

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: ARD368818998
• Device Catalogue Number: ARD368818998
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1