FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED
Received Apr 24, 2017 · Event occurred Mar 27, 2017
Report 2134070-2017-00006 · MDR key 6516707
Device
Generic name
Forceps, Biopsy, Non-electric, Reprocessed
Manufacturer
Sterilmed, Inc.Model number
MIC1333Catalog number
MIC1333
Lot number
1974707
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 TO THE MANUFACTURER FOR A FULL INVESTIGATION. THE DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE BROKE WHILE IN THE PATIENT. ADDITIONAL DETAILS WERE REQUESTED BUT NO ADDITIONAL INFORMATION IS AVAILABLE. THIS WAS NOTED AS A GENERAL COMPLAINT OF THIS HAPPENING AGAIN (THAT WAS UNDOCUMENTED AND UNREPORTED TO THE MANUFACTURER, FROM A PREVIOUS COMPLAINT OF THE SAME ISSUE.