MAUDE Adverse Event Report: I.C. MEDICAL, INC. PENEVAC1; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	ICM-000-0572
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During surgical procedure in or, surgeon placed suction bovie back in holster.The bovie pencil tubing recoiled, causing it to come out.Drapes removed.Pt assessed.Code red called.Fire alarm pulled.After event cleared, surgical procedure proceeded.Drape & bovie saved.It has been identified that after the tubing surrounding the hot cautery tip was placed inside the safety holster is recoiled back and out of the holster landing on the drape causing a burn.Although this was quickly identified, the patient was negatively impacted and placed at increased risk for ssi [surgical site infection] as the drapes had to be removed and replaced over a surgically opened joint.

• Brand Name: PENEVAC1
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): I.C. MEDICAL, INC.; 15002 n. 25th dr; phoenix AZ 85023
• MDR Report Key: 25734877
• Report Number: 25734877
• Device Sequence Number: 10483904
• Product Code: GEI
• UDI-Device Identifier: 00817688022527
• UDI-Public: (01)00817688022527
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2026
• Report Date (Section F): 07/06/2026

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: ICM-000-0572
• Device Catalogue Number: ICM-000-0572
• Device Lot Number: 9624
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/06/2026