MAUDE Adverse Event Report: MAQUET SAS SW OPERATING LIGHTS; LIGHT, SURGICAL, CEILING MOUNTED

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturer.Other text : device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with one of surgical lights related with fall of a piece.Upon inspection the technician confirmed loose cover due to loosened screws.Cover was reinstalled using screws with loctite.There was no injury reported however we decided to report the issue based on the potential as any particles falling off into sterile field or during procedure may be a source of contamination.

Manufacturer Narrative

Getinge became aware of an issue with modutec device related with fall of a piece.Upon inspection the technician confirmed loose cover due to loosened screws.Cover was reinstalled using screws with loctite.There was no injury reported however we decided to report the issue based on the potential as any particles falling off into sterile field or during procedure may be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to incident.In the time when the event occurred the device was being used for patient treatment.When reviewing similar reportable events for the same device, we have been able to establish that is single and isolated event on modutec device.The main probable root cause is incorrect tightening of covers side screws during assembly or maintenance.To prevent any similar incident it is recommended to securely tighten the screw covers and perform visual inspection during maintenance as indicated in the device manual.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: SW OPERATING LIGHTS
• 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: 9503697
• MDR Text Key: 179257402
• Report Number: 9710055-2019-00366
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

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 Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1