MAUDE Adverse Event Report: MAQUET SAS SCREEN HOLDER; HOLDER, CAMERA, SURGICAL

Model Number ARD567711910

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 13th may, 2021 getinge became aware of an issue with screen holder.The handle support has detached.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off may cause potential infection.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with screen holder.The handle support has detached.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off may cause potential infection.The problem was solved by replacing the defective part.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.At the time when the event occurred the device was not being used for the patient treatment.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.The detachment between aluminum cylinder and the handle support is probably due to mechanical shock, collisions or excessive efforts.To prevent any similar incident: - during the manufacturing the parts are degreased; - the quantity of the instant adhesive gel deposited is checked; - the adhesive bonding is checked by manual traction during the manufacturing; - the user manual #0421101 xs/xd flat screen monitors holders mentions to check the condition of the sterilizable handle.We believe that all remaining devices are performing correctly in the market.Given the circumstances and after our review of complaint ratio behavior of this nature, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

• Brand Name: SCREEN HOLDER
• Type of Device: HOLDER, CAMERA, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11841638
• MDR Text Key: 251425772
• Report Number: 9710055-2021-00194
• Device Sequence Number: 1
• Product Code: FXR
• 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,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD567711910
• Device Catalogue Number: ARD567711910
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2021
• Patient Sequence Number: 1