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

Model Number ARDVST229013A

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights, volista standop.The upper joint plate on the spring arm of the lamp has jumped out and has cut open the fleece of the laminar air flow ceiling.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

Getinge became aware of an issue with one of surgical lights - volista standop.The upper joint plate on the spring arm of the lamp has jumped out and has cut open the fleece of the laminar air flow ceiling.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, surgical lights did not meet their specification due to the dust cover, which detached and dropped out of the device posing a threat to the facilities around the surgical light, and in this way device contributed to event.It remains unknown whether the malfunction was detected by during checking the affected device or during operation.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Comparing the number of affected to number of sold devices, failure ratio is very low.According to the subject matter expert at manufacturer¿s evaluation the possible root causes are: - 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 (e131106) 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.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

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: 14117038
• MDR Text Key: 289313826
• Report Number: 9710055-2022-00123
• Device Sequence Number: 1
• Product Code: FTD
• UDI-Device Identifier: 3700712401504
• UDI-Public: (01)3700712401504
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDVST229013A
• Device Catalogue Number: ARDVST229013A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1