JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 50CM MAXI-CURVED

Additional Manufacturer Narrative

SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, SAMPLE HAS NOT BEEN EVALUATED YET. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE SAMPLE HAS BEEN REVIEWED.

Description of Event or Problem

JAWZ FORCEPS WOULD NOT OPEN TO OBTAIN A BX SPECIMEN.

Additional Manufacturer Narrative

A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. IFU UNDER PRECAUTIONS- "THE FORCEP SHOULD BE THOROUGHLY RINSED WITH HEPARINIZED SALINE PRIOR TO EACH SPECIMEN COLLECTION DURING THE PROCEDURE." ONE OPENED DEVICE WAS RETURNED FOR EVALUATION. DEVICE ONE WOULD NOT ACTUATE WHEN RECEIVED. DISTAL END OF DEVICE WAS SOAKED FOR FIFTEEN MINUTES IN ALCOHOL AND REMOVED. DEVICE WOULD THEN SLIGHTLY START TO OPEN UPON ACTUATION. JAW WAS MANIPULATED OPEN AND THEN THE DEVICE WAS SOAKED AGAIN AND PERIODICALLY ACTUATED. AFTER FINAL REMOVAL FROM ALCOHOL SOAK, THE DEVICE WOULD ACTUATE. ROOT CAUSE OF THE DEVICE NOT WORKING PROPERLY IS MOST LIKELY A FOREIGN SUBSTANCE(ORGANIC) CAUGHT IN THE CLEVIS AREA MECHANISM OF THE DISTAL TIP(JAWZ). A RESULT OF THE DEVICE NOT BEING THOROUGHLY RINSED. SINCE THIS ISSUE WAS BELIEVED TO BE CAUSED BY THE USER NOT THOROUGHLY RINSING WITH HEPARINIZED SALINE, NO CORRECTIVE ACTION IS NECESSARY. THE IFU HAS BEEN UPDATED SINCE THE MANUFACTURE OF THIS PRODUCT TO FURTHER STRESS THE IMPORTANCE OF CLEANING THE DEVICE UPON REMOVAL.

Description of Event or Problem

JAWZ FORCEPS WOULD NOT OPEN TO OBTAIN A BX SPECIMEN.