MAUDE Adverse Event Report: GENERAL MEDICAL MERATE S.P.A. DISCOVERY RF180; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problem Unintended Movement (3026)

Patient Problem Arthralgia (2355)

Event Type  malfunction  

Manufacturer Narrative

After returned to the manufacturer of the device, the investigation will be done on the device it self.

Event Description

We has been informed that during the movement of the table from -90° to 0 (horizontal position) while reaching the final position the table had a movement that caused the rear structure (opposite to the operator position) to reach the floor.Then the table stopped, an error message appeared on the display and no further movements where possible.The x-ray tech got there hand bruised by the table top and the patient was taken to the er and released with no major injuries.

Manufacturer Narrative

The situation was caused by an event regarding the endless screw, resulting in a damage of the screw itself.Gmm immediately took action to carry out the appropriate checks.The analysis is still ongoing.Based on actual information and the preliminary analysis, we do not require any immediate action on the installed base and no production stop.This is supported by following considerations: - it is the first time this kind of event happened - at the moment no other similar events has been reported - the results of metallurgical inspection was not evidencing an issue - the fem analysis was not evidencing a design issue - the laboratory verification of the screws collected from similar devices already in use did not found similar issue gmm is collecting more screws from the field in order to have a better and clearer view of the situation.We plan to complete all analysis and investigation on 31st january 2024.

Event Description

We has been informed that during the movement of the table from -90° to 0 (horizontal position) while reaching the final position the table had a movement that caused the rear structure (opposite to the operator position) to reach the floor.Then the table stopped, an error message appeared on the display and no further movements where possible.The x-ray tech got there hand bruised by the table top and the patient was taken to the er and released with no major injuries.

Manufacturer Narrative

The situation was caused by an event regarding the endless screw, resulting in a damage of the screw itself.General medical merate s.P.A.(gmm) immediately took action to carry out the appropriate checks.Based on information received and the analysis conducted, gmm do not require any immediate action on the installed base and no production stop.This is supported by following considerations: it is the first time this kind of event happened.No damage to property or major injuries to persons related to this event has been reported.At the moment no other similar events has been reported.The results of metallurgical inspection was not evidencing an issue.The fem analysis was not evidencing a design issue.The laboratory verification of the screws collected from similar devices.Already in use did not found similar issue.Gmm is conducting further checks by collecting more screws from the field.This is aimed at getting a more comprehensive understanding of entire the situation.After the already provided examination of the available information, gmm has decided to take action to improve certain components of the interested equipment to mitigate a potential risk that could reduce the safe use of the equipment.A specific kit, including all necessary parts and instructions, has been created for the relevant implementation on all the installed equipment during ordinary/extraordinary maintenance.For further details about the action plan and programming for the execution of the corrective action, see the document "fsn screw event letter eng_rev(b)(6) 2024".

Event Description

We has been informed that during the movement of the table from -90° to 0 (horizontal position) while reaching the final position the table had a movement that caused the rear structure (opposite to the operator position) to reach the floor.Then the table stopped, an error message appeared on the display and no further movements where possible.The x-ray tech got there hand bruised by the table top and the patient was taken to the er and released with no major injuries.

• Brand Name: DISCOVERY RF180
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GENERAL MEDICAL MERATE S.P.A.; via partigiani, 25; seriate, bergamo 24068 ; IT 24068
• Manufacturer (Section G): GENERAL MEDICAL MERATE S.P.A.; via partigiani, 25; seriate, bergamo 24068 ; IT 24068
• Manufacturer Contact: luca bianchessi ; via partigiani, 25; seriate, bergamo 24068 ; IT 24068
• MDR Report Key: 18019968
• MDR Text Key: 326683139
• Report Number: 3002807092-2023-00002
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K173395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 12/22/2023; 02/06/2024
• Supplement Dates FDA Received: 12/22/2023; 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1