MAUDE Adverse Event Report: MEDTRONIC, INC. VALLEY LAB HARMONIC SCALPEL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 48843056

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 10/17/2023

Event Type  malfunction  

Event Description

When pulling drapes off patient at the end of the case, two areas were blistered on the outer right hip and upper thigh.During the case it was noted that the harmonic was no longer clamping correctly and was replaced.After burns were noted, the harmonic was inspected and appeared melted.Manufacturer response for harmonic scalpel, valley lab harmonic scalpel (per site reporter) no response to date.

• Brand Name: VALLEY LAB HARMONIC SCALPEL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 18091732
• MDR Text Key: 327617211
• Report Number: 18091732
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/19/2023

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 Model Number: 48843056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14235 DA
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White