MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; GYNECOLOGICAL LAPAROSCOPIC KIT

Model Number DYNJ52564D

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The rfid tag/sensor detatched from surgical gauze.The tag was detected by rfid wanding, and removed.It had detatched from the surgical gauze.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 18621620
• MDR Text Key: 334311607
• Report Number: 18621620
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ52564D
• Device Catalogue Number: DYNJ52564D
• Device Lot Number: 23FMG368
• 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: 10/12/2023
• Date Report to Manufacturer: 02/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17223 DA