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

Model Number	PC3787
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a bubble on the end of the probe cover which causes a blank spot on the ultrasound.No patient injury, infection, or complications were reported.

• Brand Name: ECOLAB / MICROTEK
• Common Device Name: INTRAOPERATIVE PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC.; 1 ecolab pl; st. paul MN 55102
• Manufacturer (Section G): MICROTEK DOMINICANA, S.A.; las americas free zone park; autopista las americas; santo domingo, santo domingo 11606 ; DR 11606
• Manufacturer Contact: emily scott ; 1 ecolab pl; st. paul, MN 55102
• MDR Report Key: 16600150
• Report Number: 3012811961-2023-00004
• Device Sequence Number: 5996223
• Product Code: PUI
• UDI-Device Identifier: 00748426046362
• UDI-Public: 00748426046362
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: PC3787
• Device Lot Number: D220529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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