NOVAPASS REVERDIN SUTURE PASSER

Description of Event or Problem

NO ADDITIONAL INFORMATION HAS BEEN REPORTED SINCE THE SUBMISSION OF THE INITIAL REPORT ON 5/15/2018.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. CORRECTION: DATE REC¿D BY MFR-COUNTRY OF ORIGIN: AUSTRALIA. PMA/510(K) #: EXEMPT INVESTIGATION - EVALUATION A REVIEW OF THE DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS AND TRENDS WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. THE DEVICE IS INSPECTED VISUALLY AND FUNCTIONALLY FOR PROPER FUNCTION INCLUDING THE NEEDLE TIP AND TRIGGER OPERATION. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT LOT SEARCH COULD NOT BE CONDUCTED. HOWEVER, IT IS KNOWN THAT THE EVENT UNDER MFR. REPORT:1820334-2018-01469 OCCURRED ON THE SAME DAY AT THE SAME SITE. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH NOTES: ¿EXERCISE EXTREME CAUTION DURING USE OF THIS DEVICE TO AVOID UNINTENTIONAL PUNCTURE/PERFORATION OF VESSEL, NEVER, BOWEL, OR ANY OTHER INTERNAL ORGANS OR VITAL ANATOMICAL STRUCTURES.¿ ALSO, ¿DO NOT USE SUTURE PASSER IN A PROCEDURE WHERE THE POSITION OF THE NEEDLE TIP CANNOT BE CLEARLY IDENTIFIED.¿ THERE IS NO MEDICAL HISTORY FOR REVIEW COULD SHED LIGHT ON WHETHER EITHER PATIENT WAS ON ANTICOAGULANT THERAPY OR HAD BLEEDING TENDENCIES. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Additional Manufacturer Narrative

PATIENT CODE: BLOOD LOSS SELECTED FOR "BLEEDING" IS NOT LABELED; NO CODE AVAILABLE SELECTED FOR "REQUIRED INTERVENTION". DEVICE CODE: NO KNOWN DEVICE ISSUES REPORTED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS USED FOR TRANS-FACIAL SUTURES WITH SUPERIOR AND INFERIOR MIDLINE FIXATION POINTS AND 3 LATERAL FIXATION POINTS. NO PERIOPERATIVE BLEEDING WAS NOTED WAS REPORTED. HOWEVER, THE PATIENT HAD TO RETURNED TO THEATRE POST OPERATIVELY TO CONTROL BLEEDING INTO THE RECTUS MUSCLE. THE SURGEON BELIEVES THE BLEEDING WAS DUE TO USING THE REVERDIN NOVAPASS FOR THE TRANSFASCIAL SUTURES. QUESTIONS HAVE BEEN ASKED REGARDING THE PATIENT AND THE EVENT. NO FURTHER DETAILS REGARDING THE PATIENT OR EVENT HAVE BEEN PROVIDED AT THIS TIME.