MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; MAJOR

Model Number DYNJ901071J

Device Problem Material Integrity Problem (2978)

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

Event Date 03/10/2023

Event Type  Injury  

Event Description

Rfid tags came off inside the patient and were retrieved in the middle of the procedure.

Manufacturer Narrative

According to the customer, on (b)(6) 2023, during a robotic inguinal procedure 3 "raytec rfid tags" came off inside the patient and were retrieved in the middle of the procedure.The customer reported the procedure was prolonged due to the need to retrieve the tags.The customer reported there was no serious injury or additional medical intervention required related to the reported incident.A sample was requested for return evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Type of Device: MAJOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16713257
• MDR Text Key: 313027059
• Report Number: 1423395-2023-00016
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10195327232498
• UDI-Public: 10195327232498
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNJ901071J
• Device Catalogue Number: DYNJ901071J
• Device Lot Number: 23AMI057
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other