HYSAFE

Additional Manufacturer Narrative

INVESTIGATION RESULTS: THE GRASP. FORCEPS INSERT 5FR WL 340 MM, 8642.6508, LOT#4500309024 WAS INVESTIGATED BY THE RESPONSIBLE DEPARTMENT, AND THE REPORTED CONDITION WAS CONFIRMED. THE TIPS OF FORCEPS DO NOT ACTUATE. PROXIMAL END OF FORCEPS INSERT PULL-ROD WERE BROKEN OFF. THE SHAFT OF THE INSERT IS SEVERELY BENT. DURING THE INSPECTION, THE HANDLE (CONCOMITANT DEVICE) PART ID: 8083.001, LOT# 4500274682 WAS ALSO EVALUATED AND FOUND TO HAVE MET THE SPECIFICATIONS. PROBABLE ROOT CAUSE: THE PROBABLE ROOT CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE USER ERROR. THE PROXIMAL END OF THE PULLROD WAS DAMAGED AND BROKEN DUE TO EXCESSIVE FORCE ON THE DEVICE. THE USER ATTEMPTS TO DISCONNECT THE INSERT FROM THE HANDLE WITHOUT PROPERLY DISENGAGING THE LOCK THAT HOLDS IT IN PLACE. THE BENDS IN THE SHAFT ARE THE RESULT OF PULLING THE FORCEPS FROM A WORKING CHANNEL AT AN ANGLE AND/OR WITH EXCESSIVE FORCE. SECTION 9 OF GA-S016 / EN-US / 2015-03 V2.0 CAUTIONS THE LIMITED STRENGTH OF THE DEVICE AND THE POTENTIAL DAMAGE THAT CAN OCCUR FROM EXCESSIVE FORCES. MANUFACTURING ANALYSIS: THE GRASP. FORCEPS INSERT 5FR WL 340 MM, TYPE 8642.6508 WITH BATCH NUMBER 4500309024 WAS MANUFACTURED ON AUGUST 31, 2020. THE BATCH SIZE WAS (B)(4) PIECES, AND NO SPECIAL APPROVALS OR OTHER ANOMALIES WERE REPORTED. HISTORICAL DATA ANALYSIS: ON NOVEMBER 11, 2020, 43 PIECES WERE SHIPPED TO RWMIC, AND ON JANUARY 21, 2021, 1 PEACE WAS SENT TO PROGRESSIVE WOMEN'S HEALTH. A SEARCH OF THE COMPLAINTS DATABASE REVEALED NO FURTHER COMPLAINTS ABOUT THIS BATCH. IN ADDITION, (B)(4) PIECES WERE SOLD BETWEEN NOVEMBER 17, 2020, AND JANUARY 11, 2021, WITH NO FURTHER COMPLAINTS RECEIVED. IN OUR RISK ANALYSIS (B)(4), MANUFACTURING-RELATED, HANDLING-RELATED, AND DESIGN-RELATED HAZARDS RELATING TO FUNCTIONAL IMPAIRMENT, AS WELL AS RISKS POSED BY AN UNUSABLE PRODUCT, WERE CONSIDERED WITH THE CORRESPONDING EXTENT OF DAMAGE AND ASSUMED PROBABILITY OF OCCURRENCE AND WERE ASSESSED AS AN ACCEPTABLE RISK.

Description of Event or Problem

IT WAS REPORTED THAT DURING A HYSTEROSCOPY BIOPSY, THE HEALTHCARE PHYSICIAN WAS UNABLE TO TAKE A SAMPLE OF TISSUE OR POLYPS USING THE INSTRUMENT. THERE IS NO REPORT OF INJURY OR UNACCEPTABLE RISKS, HOWEVER THE PLANNED PROCEDURE COULD NOT BE COMPLETED SINCE THERE WAS NO BACK-UP DEVICE. LATER, THE PATIENT WAS REFERRED TO ANOTHER HEALTHCARE PHYSICIAN.