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

Catalog Number ARD568831963

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights volista.It was stated that cover was missing.We decided to report the issue in abundance of caution as any parts 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 manufacture date# field deem required.This is based on the internal evaluation.Previous manufacture date: 24.10.2018.Corrected manufacture date: 25.10.2018.

Event Description

Manufacturer's reference number: (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - volista.It was stated that cover was missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.As per technician¿s statement, the dust cover was refitted on the spring arm.The device passed all performance according to factory specifications and was returned to customer and cleared for clinical use.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet their specification, since the missing cover could be considered as technical deficiency, and in this way the device contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing reportable events for this type of issues we were able to establish that the received incidents of missing covers on volista surgical lights occur at a very low ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As stated by the subject matter expert the metal spring arm¿s metal cover (dust cover) came out and can fell off the device.Performed investigation allowed to distinguish possible root causes for this malfunction: ¿ non-conformity of the metal covers assembly.¿ degradation of the metal covers.¿ improper use (collision with another device).Maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file ((b)(4)) to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any action at this time.

• 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: 14771845
• MDR Text Key: 302501442
• Report Number: 9710055-2022-00224
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD568831963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• 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