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	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received a report that a sterile probe cover (pc3787), lot 7325la0100 (b)(4) unit), had a large hole/incomplete seal at the seam.No sample was returned; an image was provided and the complaint was confirmed based on the customer report and image review.Review of the edhr for lot 7325la0100 (b)(4) units manufactured 12-13 aug 2025, 1st and 2nd shift) identified no related nonconformances and the lot was manufactured and released per approved procedures.The investigation concluded a potential cause of manpower/procedure not followed (associate may have not actuated the vertrod sealer for the side seam; once folded, side seals cannot be visualized).Risk was assessed as low (risk level 1); no field action was required.A complaint notification/quality alert was issued on 17-mar-2026 and retraining was completed on 25-mar-2026.The issue will be tracked and trended (first similar incident for pc3787 within one year).
Event or Problem Description
On 27-feb-2026, the user facility reported that one (1) sterile probe cover (pc3787), lot 7325la0100, had a large hole/incomplete seal at the seam.No sample was returned; an image was provided and confirmed the incomplete seal.No patient injuries, infections, or complications were reported.

• 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; las americas free zone park; km 22, autopista las americas; santo domingo, santo domingo 11606 ; DR 11606
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL
• MDR Report Key: 24721745
• Report Number: 3012811961-2026-00006
• Device Sequence Number: 10360068
• Product Code: PUI
• UDI-Device Identifier: 00748426147779
• UDI-Public: 00748426147779
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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
• Device Lot Number: 7325LA0100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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