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

Model Number ARD568404901

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2021

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 single screen holder.The problem was crack of sterilizable handle's ring, leading to missing plastic particle.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.

Event Description

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

Manufacturer Narrative

The correction of d4 catalog #, model # and serial # deem required.This is based on the information provided from service unit.D4 previous: catalog # 567706902.Model # 567706902.Serial # (b)(6).D4 corrected: catalog # ard568404901.Model # ard568404901.Serial # (b)(6).

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with single screen holder.The problem was crack of sterilizable handle's ring, leading to missing plastic particles.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.It was established that when the event occurred, the device did not meet its specification as the ring should not crack and particles should not be missing 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.It is likely that this breakage occurred over time because of repetitive shocks.It is visually detectable during the inspection performed by the users before any surgical procedure.This case with a standard single screen holder remains isolated.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.

• 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: 11327631
• MDR Text Key: 232028434
• Report Number: 9710055-2021-00061
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568404901
• Device Catalogue Number: ARD568404901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1