FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED
Received Apr 25, 2017
Report 2134070-2017-00008 · MDR key 6520638
Device
Generic name
Forceps, Biopsy, Non-electric, Reprocessed
Manufacturer
Sterilmed, Inc.Model number
MIC1333Catalog number
MIC1333
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
CONTACT WITH THE ACCOUNT CONCERNING THE DEVICE WAS MADE. A RESPONSE WAS RECEIVED INDICATING THAT THE DEVICE(S) WILL NOT BE RETURNED FOR A FULL INVESTIGATION. SHOULD THE COMPLAINT DEVICE(S) EVER BE RECEIVED IN THE FUTURE, AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE SENT. THE DEVICE HISTORY REPORT WAS NOT REVIEWED AS NO LOT NUMBER WAS GIVEN.
Description of Event or Problem
IT WAS REPORTED THAT THE JAW WAS BENT AND THE WIRE WAS STICKING OUT OF THE JAW. BROKEN INSIDE PATIENT. NO PATIENT INJURY OR CONSEQUENCE REPORTED.