MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MEDLINE-MICROTEK; INTRAOPERATIVE PROBE COVER, 13 CM X 244 CM (5 IN X 96 IN)

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	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sterile intraoperative probe cover tore during setup in the operating room.The tear occurred at the mid cover area surrounding the ultrasound probe.No patient injuries, infections, or complications were reported.
Additional Manufacturer Narrative
The manufacturer received a report that a sterile intraoperative probe cover (sku pc3787) tore during setup in the operating room.No samples or images were returned; therefore, device evaluation was not performed.A records ased review (including dhrs for the reported lots) and assessment of manufacturing, inspection controls, equipment, and environment identified no related nonconformances.The investigation indicates an assembly technique/procedure issue (manufacturing associates; procedure not followed); assembly associates were retrained, and a quality alert was issued on january 14, 2026.Risk was assessed as low; no capa, hhe, or recall was initiated, and the issue will be tracked and trended.A similar issue has been reported previously for the same sku; a lot[?]level relationship to prior events has not been established.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: INTRAOPERATIVE PROBE COVER, 13 CM X 244 CM (5 IN X 96 IN)
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield IL
• Manufacturer (Section G): MICROTEK DOMINICANA SAS; zona franca no. 2; la romana, la romana 22000 ; DR 22000
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24097695
• Report Number: 3012811961-2026-00001
• Device Sequence Number: 10469353
• Product Code: PUI
• UDI-Device Identifier: 00748426046362
• UDI-Public: 00748426046362
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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 Model Number: PC3787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown