MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC MICROTEK; INTRAOPERATIVE PROBE COVER

Model Number	PC3787
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "for the past few months, the intraoperative probe cover drape reference (b)(4) has been continuously very easily breaking through causing contamination when we please the probe into the sterile cover.Please see pictures attached." the part shown broken in the provided picture is the tip of the probe cover.

• Brand Name: MICROTEK
• Common Device Name: INTRAOPERATIVE PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC; 1 ecolab place; st. paul 55102
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; zona franca no.2; la romana, la romana ; DR
• Manufacturer Contact: yarina montas ; 1 ecolab place; st. paul, MN 55102
• MDR Report Key: 19187719
• Report Number: 8043817-2024-00009
• Device Sequence Number: 7431758
• Product Code: PUI
• UDI-Device Identifier: 00748426046362
• UDI-Public: 00748426046362
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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: 6463LR0400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2023
• 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