NOVAPASS REVERDIN SUTURE PASSER

Additional Manufacturer Narrative

(B)(4). PRODUCT HAS NOT BEEN RECEIVED AND THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED DURING A COMPONENT SEPARATION AND ABDOMINAL WALL REPAIR IN THE ABDOMEN PROCEDURE ON A MALE PATIENT THE SURGEON PUNCTURED HIS SKIN WITH THE DEVICE. THE SURGEON STATED REPEATEDLY THAT THE DEVICE WAS SHARP, BUT DIFFICULT TO PASS THROUGH TISSUE. ON ONE OCCASION DURING THIS CASE THE SURGEON RECEIVED A SHARP INJURY TO THE FINGER OR THUMB AS A RESULT OF THE SUTURE PASSER DISTAL TIP PUNCTURING THE SKIN DURING ONE OF THE PASSES THROUGH TISSUE. THE SURGEON REMOVED THE INSTRUMENT FROM THE STERILE FIELD AND REMOVED THE GLOVE. AT THIS TIME BETADINE WAS POURED LIBERALLY ONTO THE AFFECTED AREA AND THEN RE-GLOVED. THE PROCEDURE WAS CONTINUED WITH A NEW SUTURE PASSER. EVEN WITH THE SECOND SUTURE PASSER THE SURGEON COMMENTED THAT IT WAS STILL DIFFICULT TO PASS THROUGH TISSUE AND REQUIRED SIGNIFICANT FORCE AND THEN EVENTUALLY ¿ JUST GAVE WAY".

Additional Manufacturer Narrative

INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS AND QUALITY CONTROL 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. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE; SPECIFIC ITEMS ARE ADDRESSED SUCH AS: "DO NOT USE THE SUTURE PASSER IN A PROCEDURE WHERE THE POSITION OF THE NEEDLE TIP CANNOT BE CLEARLY IDENTIFIED. NOVAPASS SUTURE PASSERS HAVE NEEDLE-POINT TIPS THAT CAN CAUSE INJURY TO INTERNAL TISSUE AND/OR ANY PERSONNEL WHO MAY COME IN CONTACT WITH THE DEVICE. THE NEEDLE-POINT TIP SHOULD BE KEPT PROTECTED WITH THE PROTECTIVE CAP WHENEVER THE DEVICE IS NOT IN USE." 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. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(4). THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED DURING A COMPONENT SEPARATION AND ABDOMINAL WALL REPAIR IN THE ABDOMEN PROCEDURE ON A MALE PATIENT THE SURGEON PUNCTURED HIS SKIN WITH THE DEVICE. THE SURGEON STATED REPEATEDLY THAT THE DEVICE WAS SHARP, BUT DIFFICULT TO PASS THROUGH TISSUE. ON ONE OCCASION DURING THIS CASE THE SURGEON RECEIVED A SHARP INJURY TO THE FINGER OR THUMB AS A RESULT OF THE SUTURE PASSER DISTAL TIP PUNCTURING THE SKIN DURING ONE OF THE PASSES THROUGH TISSUE. THE SURGEON REMOVED THE INSTRUMENT FROM THE STERILE FIELD AND REMOVED THE GLOVE. AT THIS TIME BETADINE WAS POURED LIBERALLY ONTO THE AFFECTED AREA AND THEN RE-GLOVED. THE PROCEDURE WAS CONTINUED WITH A NEW SUTURE PASSER. EVEN WITH THE SECOND SUTURE PASSER THE SURGEON COMMENTED THAT IT WAS STILL DIFFICULT TO PASS THROUGH TISSUE AND REQUIRED SIGNIFICANT FORCE AND THEN EVENTUALLY "JUST GAVE WAY".