MAUDE Adverse Event Report: I. C. MEDICAL INC. PENEVAC 1; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number ICM-000-0458

Device Problem Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

Event Type  malfunction  

Event Description

During a total hip replacement, it was discovered that the penevac 1 that was being used was not turning off.The pen continued to activate when the coag button was not being activated.Once it was discovered, the coag button was pushed again to make the pen turn off.The penevac was then taken off the sterile field.A new penevac was opened and placed on the sterile field.No pt harm related to malfunctioning device.

• Brand Name: PENEVAC 1
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): I. C. MEDICAL INC.
• MDR Report Key: 8605134
• MDR Text Key: 145083825
• Report Number: MW5086587
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ICM-000-0458
• Device Lot Number: 7171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR