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

Model Number	ORS-300
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic mitral valve repair procedure on (b)(6) 2026, the user facility reported that a disposable surgical warmer drape was later found to have a hole.The hole was identified during post-operative clean-up after the patient had already left the operating room.The warmer drape is used to maintain sterile fluid in the surgical field; the drape was found compromised with a hole.The user facility reported that no sharp instruments were placed in the drape during the procedure.No patient injuries, infections, or complications were reported.
Additional Manufacturer Narrative
A plant investigation was conducted.Edhr review for lot 1315la0600 confirmed (b)(4) units were manufactured from 28-jul-2025 to 30-jul-2025 (1st and 2nd shift).The lot was manufactured and released per approved procedures with no related nonconformances, deviations, rework, or reprocessing documented; inspection records were completed per edhr with no issues identified.The reported condition could not be replicated in manufacturing because holes are not produced in the manufacturing area, no pinch points were found, and no sharp tools/objects are used in the manufacturing process.Risk assessment resulted in low risk; no escalation was required and the issue will be tracked and trended.This is the 4th reported incident of this defect for ors-300 in a one-year period; continued monitoring will be performed and further investigation will be initiated if additional reports are received.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 FLUID WARMING SYSTEM
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield IL
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; 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: 24993098
• Report Number: 3012811961-2026-00008
• Device Sequence Number: 10450621
• Product Code: PUI
• UDI-Device Identifier: 00748426143627
• UDI-Public: 00748426143627
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/25/2026

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-300
• Device Lot Number: 1315LA0600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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