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

Model Number ARD567506996

Device Problem Corroded (1131)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 9th december, 2020 getinge became aware of an issue with single screen holder.As it was stated, the rust occurred on the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with a of an issue with single screen holder.As it was stated, the rust occurred on the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.This event is clearly due to the cleaning product.Such troubles should have been detected first by the user during daily and monthly checks.The customer¿s current cleaning product has been changed to the one recommended by the getinge.The damaged parts must be replaced as soon as possible.It was established that when the event occurred, the surgical light did not meet its specification as appearance of paint peeling is considered as technical deficiency.The device contributed to the event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could 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.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: SINGLE 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: 11044714
• MDR Text Key: 241255867
• Report Number: 9710055-2020-00512
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567506996
• Device Catalogue Number: ARD567506996
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1