MalfunctionKCT
AESCULAP
Received May 6, 2026
Report 2916714-2026-00016 · MDR key 25100894
Device
Generic name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Manufacturer
Aesculap Inc.Model number
US751Catalog number
US751
Product problems
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS FILED UNDER AIC REFERENCE (B)(4). INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WERE PIN HOLES OBSERVED IN THE FILTERS WHILE OPENING THE STERILIZATION CONTAINER FOR A PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.