MAUDE Adverse Event Report: XS SINGLE FLAT SCREEN HOLDER; HOLDER, CAMERA, SURGICAL

Model Number ARD567710900

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 13th of august 2020 getinge became aware of an issue with one of our device ¿ xs single flat screen holder.As it was stated by the customer the screen holder was not stable in the joint where it is attached to the spring arm and the screws which holds bushing on the tube were loose.No injury has been reported due to mentioned issue however we decided to report this case in abundance of caution and based on the potential as loosening of the screws could led to the detachment of the device and this further could led to serious injury.Manufacturer's reference number (b)(4).

Manufacturer Narrative

The issue is being investigated by the manufacturing site.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with the xs flat screen holder.As it was stated by the customer the screen holder was not stable in the joint where it is attached to the spring arm and the screws which hold the bushing on the tube were loose.There was no injury reported however we decided to report the issue based on the potential as any parts falling into the sterile field or during the procedure may cause a contamination.It was established that when the issue occurred, the device did not meet its specification as loose screws could be treated as technical deficiency and it contributed to the complaint.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.It was found that there is no apparent trend with the issue at hand and that the reported malfunction has never lead to serious injury or worse.Products were returned to the manufacturer for the investigation.During the devices examination it established that the mechanical play observed on the xs32 screen holder is due to loosening of screws fixing the tube to the bushing.This loosening permits that the tube can move a little bit.However, it cannot lead to the fall of the tube because the screws cannot get out from the bushing thanks to the spring arm.Handling and positioning of the screen holder is still possible with no issues.It is important to highlight that even if the screws are completely loosened they can not get out from the device and fall, but act as a pin in the tube.The system remains safe.This loosening permits that the tube can move a little bit.However, it cannot lead to the fall of the tube because the screws cannot get out from the bushing thanks to spring arm.Handling and positioning of the screen holder is still conforming to its specifications.The root cause of the screws loosening could not be established, however according to the subject matter experts at the manufacturer it could not have led to the detachment of the screen holder as even completely untightened screws cannot get out from the device and fall, but act as a pin in the tube.It is also stated by the experts that the issue cannot lead to the fall of the tube because the screws cannot get out from the bushing thanks to spring arm, and that handling and positioning of the screen holder is still conforming to its specifications.Based on the above information we would not have reported this case at the time when this complaint was registered and in the future we will not report this kind of malfunction as reportable, since the subject matter expert¿s investigation indicates that the described issue does not compromise patient safety.We believe the related devices are performing correctly in the market.

Event Description

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

• Brand Name: XS SINGLE FLAT SCREEN HOLDER
• Type of Device: HOLDER, CAMERA, SURGICAL
• MDR Report Key: 10413277
• MDR Text Key: 203115647
• Report Number: 9710055-2020-00320
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567710900
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1