FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED
Received May 2, 2017 · Event occurred Mar 29, 2017
Report 2134070-2017-00009 · MDR key 6537491
Device
Generic name
Forceps, Biopsy, Non-electric, Reprocessed
Manufacturer
Sterilmed, Inc.Model number
MIC1332Catalog number
MIC1332
Lot number
1979925
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A SUPPLEMENTAL FORM WILL BE SENT ONCE THE EVALUATION IS COMPLETED IF THE DEVICE IS RETURNED. THE DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.
Description of Event or Problem
IT WAS REPORTED THAT A STRAY WIRE WAS NOTED ON THE DEVICE. THE DEVICE WAS USED TO RETRIEVE TWO OR THREE BIOPSIES. WHEN THE NEXT BIOPSY WAS TO BE OBTAINED, IT WAS NOTICED THAT IT ¿DIDN¿T FEEL RIGHT¿ WHEN THE BIOPSY WAS OPENED. THE DEVICE WAS REMOVED AND EXAMINED, WHEN THE STRAY WIRE WAS NOTED. THE PATIENT DID NOT HAVE ANY ISSUES AFTER THE PROCEDURE, AND WAS REPORTED THAT NO PART OF THE DEVICE WAS LEFT IN THE PATIENT.