MAUDE Adverse Event Report: DANNIK LLC SUPERBAG; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	PNI0750
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Device malfunction.No description of issue relayed to reporter.Device is available for return.

• Brand Name: SUPERBAG
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): DANNIK LLC; 3201 east colonial drive; suite m3; orlando FL 32803
• MDR Report Key: 23402129
• Report Number: 23402129
• Device Sequence Number: 15973517
• Product Code: GCJ
• UDI-Device Identifier: 00850013527625
• UDI-Public: (01)00850013527625
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/03/2025
• Report Date (Section F): 10/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: PNI0750
• Device Lot Number: CEIPNI075001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Date Report Sent to FDA: 10/03/2025