MAUDE Adverse Event Report: MICROTEK DOMINICANA, S.A. MICROTEK; MICROSCOPE DRAPE

Model Number	AR8033650
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that microscope drape was opened to the field.As scrub tech was picking up supplies and organizing she found a hair stuck inside the microscope drape.This was immediately removed and operating room team broke down the sterile field because of possible contamination.No patient injury, infection, or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: MICROSCOPE DRAPE
• Manufacturer (Section D): MICROTEK DOMINICANA, S.A.; zona franca no. 2; la romana, la romana ; DR
• 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: 17762162
• Report Number: 8043817-2023-00011
• Device Sequence Number: 12454530
• Product Code: PUI
• UDI-Device Identifier: 00748426092437
• UDI-Public: 00748426092437
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2023

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: 10/01/2025
• Device Model Number: AR8033650
• Device Lot Number: 1442LR1200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 09/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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