MAUDE Adverse Event Report: Surgical Innovations Ltd LogiCut; LogiCut Mini Scissors Length 320mm

Model Number	120-7500
Medical Device Problem Codes	Material Integrity Problem (2978); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2026
Type of Reportable Event	Other

• Brand Name: LogiCut
• Common Device Name: LogiCut Mini Scissors Length 320mm
• Manufacturer (Section D): Surgical Innovations Ltd; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer (Section G): Surgical Innovations Ltd; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer Contact: stephen seed ; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 -6QZ ; UK LS16 6QZ
• MDR Report Key: 50434469
• Report Number: 9680952-2026-00007
• Device Sequence Number: 16051740
• Product Code: GEI
• UDI-Device Identifier: 05051986008226
• UDI-Public: 05051986008226
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• PMA/510(K) Number: K063485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 120-7500
• Device Lot Number: 743792
• 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: 07/03/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown