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

Model Number ARDEQT239003A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 getinge became aware of an issue with satelite ceiling mounted device holder.The spring arm's dust cover 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's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with satelite ceiling mounted device holder.The spring arm's dust cover 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 light did not meet its specification as the cover was missing and it contributed to event.There is no information whether 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 (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe that this type of our devices are performing correctly in the market.The correction of d4 serial # field deems required.This is based on the information provided by service unit.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).

• Brand Name: SATELITE
• Type of Device: HOLDER, CAMERA, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 12088432
• MDR Text Key: 260956928
• Report Number: 9710055-2021-00237
• 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
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDEQT239003A
• Device Catalogue Number: ARD567912922
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/15/2021
• Patient Sequence Number: 1