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

Model Number	PC1308
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a breast lumpectomy with sentinel node injection it was noted that the neo probe sterile drape had 2 small holes which caused the wound to be contaminated and potentially exposed the patient to pathogens.The holes were noted on microtek intraoperative probe ref number pc1308.The holes were noted on the seams of the distal end of the cover.The product involved was pc1308, 1 unit were reported as affected.No patient injuries, infections or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: INTRAOPERATIVE PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC; 1 ecolab place; st. paul MN 55102
• Manufacturer (Section G): MICROTEK DOMINICANA SA; las americas free zone park; autopista las americas; santo domingo, santo domingo ; DR
• Manufacturer Contact: yarina montas ; 1 ecolab place; st. paul, MN 55102
• MDR Report Key: 18955905
• Report Number: 3012811961-2024-00005
• Device Sequence Number: 17262925
• Product Code: PUI
• UDI-Device Identifier: 00748426053384
• UDI-Public: 00748426053384
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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: PC1308
• Device Lot Number: 7343LA1100
• 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: 02/23/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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