CRILE FCPS 5-1/2 CVD SATIN

Additional Manufacturer Narrative

THE 5-1/2 CURVED SATIN CRILE FORCEPS (106121) WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, AN EVALUATION OF THE PHYSICAL DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION WAS PROVIDED; MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. PER VISUAL EVALUATION OF THE PROVIDED IMAGES, THE CRILE FORCEPS HAD ONE OF THE JAWS SHEARED OFF. DAMAGE TO THE JAWS MAY BE THE RESULT OF ROUGH HANDLING OR ENVIRONMENTAL DAMAGE. THE REPORTED COMPLAINT WAS CONFIRMED. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.

Description of Event or Problem

A FACILITY REPORTED THAT DURING A CARDIAC PROCEDURE, THE JAWS OF THE 5-1/2 CURVED SATIN CRILE FORCEPS (106121) BROKE OFF INTO THE PATIENT'S OPERATIVE SITE. THE BROKEN PART WAS RETRIEVED. NO PATIENT INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.