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

Model Number	PC3787
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the probe broke through the probe cover during surgery.No patient infection, injury, or complications were reported.
Additional Manufacturer Narrative
Provided lot number in section d4.Previously, the part number was entered instead of the lot number, in error.
Event or Problem Description
It was reported that the probe broke through the probe cover during surgery.No patient infection, injury, or complications were reported.

• Brand Name: ECOLAB/ MICROTEK
• Common Device Name: INTERAOPERATIVE 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: 16158548
• Report Number: 3012811961-2023-00002
• Device Sequence Number: 7470058
• Product Code: PUI
• UDI-Device Identifier: 50748426046367
• UDI-Public: 50748426046367
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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
• Device Expiration Date: 11/01/2024
• Device Model Number: PC3787
• Device Catalogue Number: N/A
• Device Lot Number: D221489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2022
• 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