VISTASEAL DUAL APPLICATOR

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). D4 UDI NUMBER: UDI/GTIN UNAVAILABLE AS THIS DEVICE IS FROM A KIT. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ¿ DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? ¿ WHAT IS THE TOTAL NUMBER OF PROCEDURES? ¿ HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). ¿ IF THIS EVENT OCCURRED IN MULTIPLE PROCEDURES, PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH PATIENT EVENT: 1. IS THE USER A NEW USER TO VISTASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? 2. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? 3. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? 5. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? 6. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? 7. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND HEMOSTATIC AGENT DUAL APPLICATOR DEVICE WAS USED. DURING AN UNKNOWN PROCEDURE, THE SCRUB NURSE WAS UNABLE TO REMOVE THE TIP FROM THE APPLICATOR TO ATTACH IT TO THE ROBOTIC ATTACHMENT USING THE SAME PRODUCT. THE ISSUE OCCURRED TWICE WITH THE SAME PRODUCT. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.