MAUDE Adverse Event Report: SMITH & NEPHEW INC. MOTOR DRIVE UNITS (MDUS); ARTHROSCOPE

Model Number 72200873

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585)

Patient Problem Burn, Thermal (2530)

Event Date 09/24/2019

Event Type  Injury  

Event Description

A (b)(6) y/o female underwent a left knee arthroscopy with arthroscopic irrigation and debridement.During the procedure, an odor was noted by the scrub nurse.Circulator checked the ortho tower.Operating room staff noted the shaver handle to be hot and smoke coming from the shaver cord.Circulator attempted unsuccessfully to remove the cord; she disconnected the tower from the main wall receptacle.Drapes over pt appeared to be intact.Surgeon continued closing.Postoperatively pt was examined and a red raised area was noted on her right knee.Surgeon applied silvadene ointment and a dry dressing to the affected area.After the procedure, operating room staff noticed that part of the drape melted to the shaver cord."see add'l sheet with 2nd device info on it." consult for vascular surgeon completed to examine the burn on (b)(6) 2019.Recommendation to continue current treatment of silvadene.F/u at the wound care center after discharge.

• Brand Name: MOTOR DRIVE UNITS (MDUS)
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW INC.
• MDR Report Key: 9179825
• MDR Text Key: 162297423
• Report Number: MW5090344
• Device Sequence Number: 1
• Product Code: HRX
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72200873
• Device Catalogue Number: 72200873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 86