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

Model Number	APC1290
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a tear in the probe cover, which was spotted at the opening of the cover.No patient infection or patient injury was reported.

• Brand Name: MICROTEK MEDICAL INC.
• Common Device Name: PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC.; 1 ecolab pl; st. paul MN 55102
• Manufacturer (Section G): MICROTEK DOMINICANA, S.A.- LA ROMANA; zona franca no. 2; la romana, la romana ; DR
• Manufacturer Contact: emily scott ; 1 ecolab pl; st. paul, MN 55102
• MDR Report Key: 12806722
• Report Number: 8043817-2021-00006
• Device Sequence Number: 20220768
• Product Code: PUI
• UDI-Device Identifier: 50748426107372
• UDI-Public: 50748426107372
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 02/01/2026
• Device Model Number: APC1290
• Device Lot Number: D210551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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