DOVER

Description of Event or Problem

THE CUSTOMER REPORTED A 51-YEAR-OLD MALE PATIENT WITH PMH OF STAGE IV RECTAL CANCER PRESENTED FOR AN OUTPATIENT RECTAL MRI. TWO, 60 ML PISTON SYRINGES WERE PREPARED WITH CONTRAST AND CAPPED PRIOR TO THE EXAM. THE RADIOLOGIST WAS UNAWARE OF THE SYRINGES BEING CAPPED AND DID NOT SEE THE CLEAR (COLORLESS) CAPS PRIOR TO INJECTION. UPON REVIEW OF THE IMAGES FOR ANGULATION, IT WAS NOTED THAT THERE WAS AN ARTIFACT. ARTIFACTS RESEMBLED THE CAPS FROM THE SYRINGES. THE CLEAR SYRINGE CAPS WERE LOST IN THE PATIENT¿S REMNANT RECTUM WHEN RECTAL CONTRAST WAS INJECTED. THE SURGICAL TEAM WAS UNABLE TO RETRIEVE THE CAPS MANUALLY DUE TO STRICTURE. THE PATIENT WAS SENT FOR A SIGMOIDOSCOPY. A FOREIGN BODY WAS FOUND IN THE RECTUM. REMOVAL OF TWO SYRINGE CAPS WAS ACCOMPLISHED WITH A RAT-TOOTHED FORCEPS. A DIFFUSE AREA OF FRIABLE MUCOSA WITH SPONTANEOUS BLEEDING WAS FOUND FROM 0 TO 10 CM PROXIMAL TO THE ANUS.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.