MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGA SOFT; ELECTROSURGICAL, CUTTING, COAGULATION

Model Number 0845

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abrasion (1689); Contusion (1787)

Event Date 01/22/2018

Event Type  malfunction  

Event Description

While using the pad during electrocautery, the patient experienced an abrasion and contusion that does not necessarily look like a burn.The pad was returned to megadyne for evaluation and met all testing requirements.The pad was physically intact and was not out of date.The pad was returned to the surgical center and placed back in use.It is possible that this small patient which had a tonsillectomy and involved the head/neck was placed on jelly roll for positioning.This roll was placed on top of the megasoft pad instead of underneath, which may have reduced the surface area on the pad.However, if contact was to low the esu would not function.

Manufacturer Narrative

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Event Description

While using the pad during electrocautery, the patient experienced a second degree burn.The pad was returned to megadyne for evaluation and met all testing requirements.The pad was physically intact and was not out of date.The pad was returned to the surgical center and placed back in use.It is possible that this small patient which had a tonsillectomy and involved the head/neck was placed on a jelly roll for positioning.This roll was placed on top of the megasoft pad instead of underneath, which may have reduced the surface area on the pad.However, if contact was to low the esu would not function.

• Brand Name: MEGA SOFT
• Type of Device: ELECTROSURGICAL, CUTTING, COAGULATION
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7276746
• MDR Text Key: 100297588
• Report Number: 7276746
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018,02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/01/2019
• Device Model Number: 0845
• Device Catalogue Number: 0845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2018
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR
• Patient Weight: 16