MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MEDLINE-MICROTEK; GENERAL PURPOSE PROBE COVER

Model Number	GPC396EU
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation reviewed manufacturing records, process controls, and complaint trends.No sample or photos were returned; defect could not be reproduced.Lot history showed compliance with specifications and no deviations.No material, equipment, or environmental issues identified.Risk assessment: overall risk level low.Root cause undetermined; possible user handling factors cannot be excluded.No corrective action or field safety notice required; event will be monitored.
Event or Problem Description
It was reported that during a lumpectomy with sentinel lymph node biopsy, the protective sterile probe cover was found to have a breach at the tip after the procedure.Blood was observed on the underlying probe, which is not sterilizable and is intended to remain isolated from tissue contact.The breach compromised the sterile barrier and posed a potential infection risk.The affected cover was discarded, and a replacement sterile cover was applied.No patient harm occurred, and the procedure was completed without delay.No patient injuries, infections, or complications were reported.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: GENERAL PURPOSE PROBE COVER
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield 60093
• Manufacturer (Section G): MICROTEK DOMINICANA SAS; zona franca no. 2; la romana, la romana 22000 ; DR 22000
• Manufacturer Contact: yarina montas ; three lakes drive; northfield 60093
• MDR Report Key: 23717237
• Report Number: 8043817-2025-00011
• Device Sequence Number: 8910013
• Product Code: PUI
• UDI-Device Identifier: 00748426090204
• UDI-Public: 00748426090204
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: GPC396EU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown