MAUDE Adverse Event Report: I.C. MEDICAL, INC. ULTRA VAC SMOKE EVACUATION CAUTERY MEGADYNE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 211010J

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2020

Event Type  malfunction  

Event Description

Megadyne (i.C.Medical) ultra vac cautery pencil would not function.Replaced with "like" device that functioned without incident.Fda safety report id #: (b)(4).

• Brand Name: ULTRA VAC SMOKE EVACUATION CAUTERY MEGADYNE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): I.C. MEDICAL, INC.; phoenix AZ 85023
• MDR Report Key: 10105002
• MDR Text Key: 194051572
• Report Number: MW5094764
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 211010J
• Device Catalogue Number: 211010J
• Device Lot Number: 7737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR