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	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the warmer drape melted a hole while in use contaminating the contents of the container it was holding, (ns, as reported by the user).No patient injuries, infections or complications were reported.
Additional Manufacturer Narrative
On 13-mar-2026, a user facility reported that a warmer drape melted and developed a hole while in use, contaminating the ns it was holding; no patient injuries, infections, or complications were reported.The suspect device is ors-100 (warmer drape), lot: 4465la0600 (udi: (b)(4); the device was not available/returned for evaluation, so no physical examination was performed.A record-based plant investigation (edhr review) for lot: 4465la0600 (b)(4) units manufactured 13-14 nov 2025) confirmed manufacture and release per approved procedures with no related nonconformance's, deviations, rework, or reprocessing documented, and inspections were completed per edhr; the defect could not be replicated in manufacturing and applicable controls/procedures (including wi-dr-034 rev.40 and form-corp-0375 rev.B) were deemed adequate.Risk assessment determined low risk (occurrence 1; severity 2; risk level 1) with no escalation required (track and trend); actions included complaint notification and a quality alert (08-apr-2026).The investigation conclusion remains undetermined/inconclusive due to lack of sample/images/videos; a potential contributor could be misuse or equipment malfunction (heat under drape).This report is submitted as a 30-day malfunction/product problem report.

• 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 domingo, santo domingo 11606 ; DR 11606
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL
• MDR Report Key: 24847950
• Report Number: 3012811961-2026-00007
• Device Sequence Number: 5624469
• Product Code: PUI
• UDI-Device Identifier: 00748426143603
• UDI-Public: 00748426143603
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/10/2026

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: 4465LA0600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2025
• 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