MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; PLASTIC SURGERY AND ACCESSORIES KIT

Model Number DYNJ49652C

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  malfunction  

Event Description

The cautery smoke evac was not working properly during the procedure.This suppley came in the scripps plastic pack.The smoke evac function was not working while the bovie was in use.A different smoke evac cautery was used and it eventually worked however, the smoke evacuation was reported to not be very effective.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: PLASTIC SURGERY AND ACCESSORIES KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 17622974
• MDR Text Key: 321961152
• Report Number: 17622974
• Device Sequence Number: 1
• Product Code: FTN
• 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: 08/02/2023

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: DYNJ49652C
• Device Catalogue Number: DYNJ49652C
• Device Lot Number: 1023EMH052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2023
• Date Report to Manufacturer: 08/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA