THE INFORMATION PROVIDED IDENTIFIES THAT THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE. ARISTA? AH IS INDICATED IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL AND OPHTHALMIC) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE, AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL. AS REPORTED HEMOSTASIS WAS ACHIEVED PRIOR TO THE USE. THE DOCTOR IS ALLEGED TO HAVE USED THE ARISTA FOR, ?EXTRA PRECAUTION AND TO REDUCE THE ADHESIONS?. AS REPORTED, THE EXCESS ARISTA? AH MATERIAL WAS NOT REMOVED FROM THE SITE OF APPLICATION BY IRRIGATION AND/OR ASPIRATION BUT WAS LEFT IN VIVO. THE DIRECTIONS FOR USE STATE, A LIBERAL AMOUNT OF ARISTA? AH SHOULD BE APPLIED TO THE BLEEDING SITE FOLLOWED BY PRESSURE UNTIL HEMOSTASIS IS ACHIEVED. AFTER HEMOSTASIS IS ACHIEVED, ARISTA? AH SHOULD BE REMOVED BY IRRIGATION AND/OR ASPIRATION. OUR INSTRUCTIONS FOR USE (IFU) WARNS THE USER THAT EXCESS ARISTA? AH SHOULD BE REMOVED FROM THE SITE OF APPLICATION BY IRRIGATION AND ASPIRATION. THE POSSIBILITY OF THE PRODUCT INTERFERING WITH NORMAL FUNCTION AND/OR CAUSING COMPRESSION NECROSIS OF SURROUNDING TISSUE DUE TO SWELLING IS REDUCED BY REMOVAL OF EXCESS DRY MATERIAL. BASED ON THE INFORMATION PROVIDED THE MOST PROBABLE ROOT CAUSE APPEARS TO BE A USE OF DEVICE ISSUE. PRODUCT WAS NOT USE IN ACCORDANCE WITH THE INSTRUCTIONS-FOR-USE. USED ON PATIENT.
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Patient 1
IT WAS REPORTED THAT A SURGEON USED ARISTA AH AND (NON-DAVOL) SURGICEL ON A PATIENT HAVING A MYOMECTOMY, 25 DAYS LATER SHE DEVELOPED A LUMP WHICH SCAN SUGGESTED IS A FISTULA. A MYOMECTOMY WAS DONE TO A UTERUS THAT WAS EXTERIORIZED AND WAS PUT INSIDE THE ABDOMEN. AS REPORTED HEMOSTASIS WAS ACHIEVED BEFORE USING THE ARISTA. IT WAS REPORTED TO BE USED FOR ?EXTRA PRECAUTION AND TO REDUCE THE ADHESIONS?. AFTER USE, DIRECT PRESSURE WAS NOT APPLIED TO THE SITE AND THE RESIDUAL ARISTA MATERIAL WAS NOT REMOVED FROM THE SITE OF APPLICATION. AS REPORTED, THERE WERE NO COMPLICATING FACTORS IN THE PROCEDURE. CUSTOMER REPORTS THAT THIS WAS A VERY CLEAN PROCEDURE AND NO PURULENT MATERIAL WAS PRESENT IN THE WOUND AT THE TIME OF USE. PATIENT WAS ANTI-COAGULATED ONLY AFTER THE SURGICAL PROCEDURE. PATIENT DID NOT HAVE ANY IMMEDIATE POST-OPERATIVE COMPLICATIONS BUT HAS HAD MILD PYREXIA. PATIENT HAD A CT SCAN 3 DAYS AFTER THE OPERATION THAT DID NOT SHOW ANY SIGMOID INJURY BUT SHOWED THE ARISTA AND SURGICELL AS A COLLECTION. SHE HAD DIARRHEA 21 DAYS AFTER THE OPERATION AND IT WAS BELIEVED THAT THERE COULD HAVE BEEN DIVERTICULUM IN THE SIGMOID THAT WAS WEAKENED INTERNALLY POSSIBLY BY INFECTION, POSSIBLY BY REACTION TO ARISTA.