MalfunctionFSM
SCALPEL HOLDER RED, STERILE
Received Jul 7, 2026 · Event occurred Jun 1, 2026
Report 3002750084-2026-00076 · MDR key 25738718
Device
Generic name
Scalpel Holder
Manufacturer
Aspen Surgical Products, Inc.Model number
ST-100Lot number
510569
Product problems
- Unsealed Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION, BUT PICTURES OF THE DEVICE AND PACKAGING WERE PROVIDED. VISUAL ASSESSMENT DETERMINED THAT THE SAMPLES HAD A FAILING SEAL DUE TO SEALING OVER TOP OF A SPLICE IN THE TYVEK. THE ROOT CAUSE IS A MANUFACTURING ERROR. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
COMPLAINANT ALLEGES "STERILIZED SEAL FAILURE".