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

Model Number ARD568217113A - SUSPENSION

Device Problem Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is still being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2019 maquet sas became aware of an issue with one of devices- satellite.As it was stated, the paint is flaking off.There was no injury reported however we decided to report the issue in abundance of caution as any paint particles falling off from the parts of surgical light into sterile field or during procedure may be a source of contamination.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Manufacturer Narrative

Getinge became aware of an issue with one of devices- ¿satelite¿.As it was stated, the paint is found to be flaking off the surface of a suspension arm.There was no injury reported however we decided to report the issue in abundance of caution as any paint particles falling off from the parts of surgical light into sterile field or during procedure may be a source of contamination.It was established that when the event occurred, the device did not meet its specification and it contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.The problem has been in details discussed with the supplier, as a result two main reasons where identified, which could have led to this premature oxidation.One possibility is a deviation of the production process parameters and another possibility is a mistake during manufacturing operation handling with the supplier at the time of production of the involved arm.Given that there is a very low defect quantity the parameter-issue issue seems to be very unlikely.Therefore the most likely root cause appears to be an incorrect operation handling for pre-treatment, the improper protection after rust or incomplete drying after rust process would have led to the containment and oxidization.It should be emphasized that these main arms were painted by a previous supplier who is no longer getinge supplier since (b)(6)2016.We believe that remaining devices are performing correctly in the market.

Event Description

Manufacturer reference number: 224737.

• 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: 8752231
• MDR Text Key: 149782141
• Report Number: 9710055-2019-00210
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568217113A - SUSPENSION
• Device Catalogue Number: ARD568217113A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1