MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MICROTEK; PROBE CVR INTRAOP 5X96IN STRT W-GEL

Model Number	PC3787
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the product broke immediately prior to use.Specifically, the probe tip detached from the drape.No patient injuries, infections, or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: PROBE CVR INTRAOP 5X96IN STRT W-GEL
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; las americas free zone park; km 22, autopista las americas; santo ddmingo, santo ddmingo 11606 ; DR 11606
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22916517
• Report Number: 3012811961-2025-00008
• Device Sequence Number: 9878955
• Product Code: PUI
• UDI-Device Identifier: 00748426046362
• UDI-Public: 00748426046362
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: PC3787
• Device Lot Number: 2434LA0800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown