MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0847

Device Problem Use of Device Problem (1670)

Patient Problems Abrasion (1689); Erythema (1840); Blister (4537); Unspecified Tissue Injury (4559)

Event Date 12/15/2022

Event Type  malfunction  

Event Description

Two patient skin injuries occurred in the same operating room with the same equipment within two weeks of each other.Both patients were in the supine position.The injuries were to the patients back and arms where the skin was in direct contact with the megadyne (ethicon) return pad.The first case was a five hour laparoscopic colectomy.The skin breakdown was describe as erythema and blistering over the upper back scapula area on the left and right sides, on the right posterior shoulder area, on the left posterior arm, and on the right forearm.The second case was a ten hour complex edg that became an open laparotomy.The skin breakdown was described as abrasions in dark red maroon color with underlying erythema on the back.In both cases the skin wounds were significant and were treated with silver foaming dressing.

• Brand Name: MEGADYNE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 16408416
• MDR Text Key: 309878400
• Report Number: 16408416
• 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: 01/26/2023,12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0847
• 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: 01/26/2023
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• 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: 5840 DA
• Patient Sex: Male
• Patient Race: White