MalfunctionKKX
ENDOCAVITY PROBE COVER; 3.5CM X 20CM
Received May 13, 2026
Report 3002750084-2026-00044 · MDR key 25164579
Device
Generic name
Endocavity Probe Cover
Manufacturer
Aspen Surgical Products, Inc.Model number
1-519-3230CILot number
439530
Product problems
- Material Puncture/Hole
- Material Perforation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
COMPLAINANT ALLEGES "THE ITEM # IS 934412 AND OUR CLINICAL STAFF HAS BEEN FINDING HOLES IN THEM WHEN THEY PUT THE PROBE COVER OVER THE PROBE. YOU CAN'T SEE THE HOLES UNTIL THE COVER IS STRETCHED OUT, IF THAT MAKES SENSE."
Additional Manufacturer Narrative
THE DEVICE IS IN PROCESS OF BEING RETURNED FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.