inforMED
MalfunctionEKD

ADSN TISS FCPS 4-3/4 1X2

Received Jun 26, 2014 · Event occurred Jun 2, 2014

Report 2523190-2014-00047 · MDR key 3958804

Device

Generic name

M5-general Surgery

Catalog number

6-120

Lot number

UNK

Product problems

  • Break

Patient

30 YR

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

Description of Event or Problem

CUSTOMER INITIALLY REPORTS TEETH BROKE WHILE TREATING PT. ON (B)(6) 2014, CUSTOMER REPORTS TIP FROM THE ONE TOOTH SIDE OF FORCEP BROKE OFF IN PT LIP WHEN A BIOPSY WAS BEING TAKEN. TIP WAS REMOVED EASILY. NO HARM TO PT. EVENT DATE NOT AVAILABLE, (B)(6).