MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MEDLINE-MICROTEK; WARMER DRAPE, FOR USE WITH ORS-2000 SERIES

Model Number	ORS-100
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received a report that a sterile drape warmer cover (ors-100), lot 3265la0400 ((b)(4) unit), had microscopic holes on the bottom.No sample was returned; an image was provided and the complaint was confirmed based on the customer report and image.Review of the edhr for lot 3265la0400 ((b)(4) units manufactured 26-27 jun 2025) identified no related nonconformances and the lot was manufactured and released per approved procedures.The condition could not be replicated and the investigation was inconclusive regarding where the nonconformance was generated due to lack of returned sample.Risk was assessed as negligible/low; no field action was required.A quality alert/complaint notification was issued on 09-feb-2026 and the issue will be tracked and trended (fourth similar incident for ors-100 within one year).
Event or Problem Description
Customer reported that the item had microscopic holes on the bottom.One unit (ors-100 drape warmer) from lot 3265la0400 was reported as affected.No patient injuries, infections or complications were reported.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: WARMER DRAPE, FOR USE WITH ORS-2000 SERIES
• 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 ddmingo, santo ddmingo 11606 ; DR 11606
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL
• MDR Report Key: 24328096
• Report Number: 3012811961-2026-00004
• Device Sequence Number: 15833664
• Product Code: PUI
• UDI-Device Identifier: 00748426143603
• UDI-Public: 00748426143603
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/12/2026

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: ORS-100
• Device Lot Number: 3265LA0400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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