MAUDE Adverse Event Report: MAQUET SAS PRISMALIX; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD267200110

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 21st december, 2020, getinge became aware of an issue with prismalix surgical light.As it was stated, the metal strip was missing.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.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with prismalix surgical light.As it was stated, the metal strip was missing.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.It was established that when the event occurred, the surgical light did not meet its specification as covers should not fall and it contributed to incident.There is no information if in the time when the event occurred, the device was or was not being used for patient treatment.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 ((b)(4)) to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.The purpose of this submission is solely to provide a correction of serial# section.This is based on the result of additonal information provided by sales and service unit.#d4: previous serial#: (b)(6).Corrected serial#: (b)(6).

• Brand Name: PRISMALIX
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11063930
• MDR Text Key: 223410219
• Report Number: 9710055-2020-00522
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD267200110
• Device Catalogue Number: ARD267200110
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1