BIOPSY FORCEP
Received Mar 9, 2026 · Event occurred Feb 3, 2026
Report 1016427-2026-00014 · MDR key 24546190
Device
Generic name
Device, Biopsy, Endomyocardial
Manufacturer
Cordis Us. CorpModel number
N/ACatalog number
504302
Lot number
70225263
Product problems
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DUE TO SYSTEM LIMITATIONS, SECTION H6 REQUIRED TO INPUT TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS FOR AN INITIAL REPORT. PENDING ADDITIONAL INFORMATION TO COMPLETE INVESTIGATION. THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
Description of Event or Problem
AS REPORTED, FOREIGN MATERIAL WAS REPORTED IN THE JAW OF A 5.5F BIOPSY FORCEPS UPON OPENING. UPON INSPECTION, THE JAW DID NOT OPEN, SO THE INNER SURFACE WAS NOT ABLE TO BE EXAMINED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.