MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC. MICROTEK; INTRAOPERATIVE PROVE 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	10/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ecolab received medwatch report (mw5104996) for this event from the fda.
Event or Problem Description
It was reported that a probe cover broke and contaminated a stent while the probe was being used to check stent placement.The stent was then removed from the patient.The area and instruments were cleaned and a new stent was placed.No patient infection, injury, or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: INTRAOPERATIVE PROVE 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: 13806216
• Report Number: 3012811961-2022-00001
• Device Sequence Number: 4993328
• Product Code: PUI
• UDI-Device Identifier: 50748426046367
• UDI-Public: 50748426046367
• Combination Product (Y/N): N
• 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: Consumer,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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: 08/01/2025
• Device Model Number: PC3787
• Device Lot Number: D202169
• 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: 01/24/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2020
• 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