MalfunctionKCT
AESCULAP
Received Jun 25, 2026 · Event occurred May 20, 2026
Report 1319130-2026-00006 · MDR key 25627391
Device
Generic name
Round Filters W/indicator
Manufacturer
Crosstex International Inc.Model number
US751Catalog number
US751
Product problems
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED TO CROSSTEX FOR EVALUATION. SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR US751, WITHIN THE PAST YEAR. NO LOT CODE HAS BEEN PROVIDED TO REVIEW DHR OR RETENTION SAMPLES. MICRO PINHOLES OBSERVED IN ALL HIGHLIGHTED FILTERS. NONE ARE ABLE TO BE QUANTIFIED WITHOUT MICROSCOPY. INVESTIGATION IS STILL ONGOING.
Description of Event or Problem
DISTRIBUTOR REPORTED THAT THE END USER IS SEEING HOLES ON THE FILTERS IN SURGERY.