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

Model Number ARD568805901

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On 30th july, 2020 getinge became aware of an issue with one of surgical lights - volista access.As it was stated, the circlip inside the sterilizable handle broke.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may lead to contamination.

Manufacturer Narrative

Issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - volista access.As it was stated, the circlip inside the sterilizable handle broke.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may lead to contamination.Based on ssu technician¿s statement, the broken circlip was replaced and installed back to fix the issue.It was established that when the event occurred, the surgical light did not meet its specification due to broken circlip of the sterilizable handle, which contributed to the event.Provided information indicate that upon the event occurrence the device was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of the broken sterilizable handle circlip on volista access occurrence is very low.As stated by subject matter expert at manufacturer¿s, the circlips fitted on the qlcs adaptor broke, hence the qlcs device couldn¿t be locked anymore.So far, the reason of this circlips breakage remains unkown because it is dimensioned for the strength applied on it and no oxidation can occur at this location.Furthermore, this is isolated case.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: VOLISTA ACCESS
• 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: 10361502
• MDR Text Key: 201563823
• Report Number: 9710055-2020-00246
• Device Sequence Number: 1
• Product Code: FTD
• UDI-Device Identifier: 3700712401290
• UDI-Public: (01)3700712401290
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568805901
• Device Catalogue Number: ARD568805901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1