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

Model Number	APC1292
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customers have reported a problem with the probe cover.When installing the protection on the probe, the part of the end of the cover that is supposed to stick to the probe does not.The adhesive remains on the white part of the label and not on the cover.No patient injuries, infections, or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: ADHESION¿ INTRAOPERATIVE PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC; 1 ecolab place; st. paul MN 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: 19235389
• Report Number: 8043817-2024-00010
• Device Sequence Number: 18130741
• Product Code: PUI
• UDI-Device Identifier: 00748426107407
• UDI-Public: 00748426107407
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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 Expiration Date: 04/08/2026
• Device Model Number: APC1292
• Device Lot Number: 6103LRD100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2023
• 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