MAUDE Adverse Event Report: SOPHYSA LUMBO-PERITONEAL SOPHY® SM8 KIT PREATTACHED; SM8-2040

Model Number	SM8-2040
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A children was having a control mr scan after the placement of a peritoneal ventricle shunt (from the brain, under the skin to the abdominal region).The patient was placed on the mr table and positioned.Right after being positioned the patient informed his mother (that was on the room with him) that he felt movement of the shunt in the abdominal region.The patient was removed from the system and evaluated by the team that had operated him.The information we have at the moment is that no serious injury has occurred, but the patient will have to be submitted to another surgery to correct the placement of the shut in the abdominal region.
Additional Manufacturer Narrative
"in this case, the product involved in the incident is an sm8-2040, which is not registered on the us market.Therefore, this incident should not have been reported this report is being resubmitted because previous reports sent on 01/10/2025 and 01/30/2025 were not accepted.
Event or Problem Description
A children was having a control mr scan after the placement of a peritoneal ventricle shunt (from the brain, under the skin to the abdominal region).The patient was placed on the mr table and positioned.Right after being positioned the patient informed his mother (that was on the room with him) that he felt movement of the shunt in the abdominal region.The patient was removed from the system and evaluated by the team that had operated him.The information we have at the moment is that no serious injury has occurred, but the patient will have to be submitted to another surgery to correct the placement of the shut in the abdominal region.

• Brand Name: LUMBO-PERITONEAL SOPHY® SM8 KIT PREATTACHED
• Common Device Name: SM8-2040
• Manufacturer (Section D): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 20733421
• Report Number: 3001587388-2024-24386
• Device Sequence Number: 15690765
• Product Code: JXG
• UDI-Device Identifier: 03760124131093
• UDI-Public: 03760124131093
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K013488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SM8-2040
• Device Catalogue Number: SM8-2040
• Device Lot Number: 23092131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: REMOVAL OF REPORT #30015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male