VISTASEAL DUAL APPLICATOR

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). D4 UDI NUMBER: UDI/GTIN UNAVAILABLE AS THIS DEVICE IS FROM A KIT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IS THE USER A NEW USER TO VISTASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? NOT A NEW USER. SURGEON ALREADY USED THIS PRODUCT A HUNDRED TIMES. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? A HUNDRED TIMES. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? SALES REP IS PRESENT DURING THE CASE. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? SALES REP COULD NOT SEE AS HE DON'T HAVE THE PRODUCT. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? - NO PICTURES OF THE PRODUCTS. ADDITIONAL INFORMATION: D4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: 3661643 AND 365507. 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 A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2026 AND HEMOSTATIC AGENT DUAL APPLICATOR DEVICE WAS USE. DURING THE PROCEDURE, THE USER REPORTED THAT THE OBTURATOR TIP SUPPLIED WITH THE PRODUCT COULD NOT BE REMOVED BECAUSE IT WAS STUCK. AS A RESULT, THE LAPAROSCOPIC TIP COULD NOT BE ATTACHED AND THE DEVICE COULD NOT BE USED AS INTENDED. A NEW PRODUCT WAS OPENED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.