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

Model Number ICM-000-0452

Device Problem Self-Activation or Keying (1557)

Patient Problem Laceration(s) (1946)

Event Date 03/07/2019

Event Type  malfunction  

Event Description

During the case the hand piece began to cut on its own.There was no one touching the handle.It left an inch cut on the patient's thigh of the operative leg.The surgeon was immediately notified.The cautery handle was removed from the surgical field.

• Brand Name: PENEVAC
• Type of Device: ELECTROSURGICAL, CUTTING, COAGULATION
• Manufacturer (Section D): I.C. MEDICAL, INC.; 15002 n. 25th dr.; phoenix AZ 85023
• MDR Report Key: 8431580
• MDR Text Key: 139168248
• Report Number: 8431580
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ICM-000-0452
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19345 DA
• Patient Weight: 70