MAUDE Adverse Event Report: MICROTEK MEDICAL, INC. MICROTEK INTRAOPERATIVE PROBE COVER; DRAPE, SURGICAL

Model Number	PC3787
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Vascular lab probe was being used to check carotid stent placement, probe cover broke and contaminated stent.Stent was removed from patient, contaminated items removed from field.Area and instruments cleaned with betadine paint.New stent opened and placed.Fda safety report id # (b)(4).

• Brand Name: MICROTEK INTRAOPERATIVE PROBE COVER
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): MICROTEK MEDICAL, INC.
• MDR Report Key: 12711426
• Report Number: MW5104996
• Device Sequence Number: 4550119
• Product Code: FYA
• UDI-Device Identifier: 00748426046362
• UDI-Public: (01)00748426046362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2021
• 2 Devices were Involved in the Event: 1 2

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: 06/14/2023
• Device Model Number: PC3787
• Device Lot Number: D202169
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1