J-VAC RESERVOIR

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (b)(6) 2026 AND A RESERVOIR WAS USED. DURING PROCEDURE, THE NEGATIVE PRESSURE COULD NOT BE APPLIED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (b)(4).ADDITIONAL INFORMATION: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.ADDITIONAL INFORMATION PROVIDED:IT OCCURRED WITH 2 PRODUCTS IN A ROW.ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.- DID THE RESERVOIR FUNCTION PROPERLY UPON FIRST ACTIVATION?=>UNK- IF YES, HOW LONG AFTER THE FIRST ACTIVATION HAPPENED DID THE ISSUE OCCURRED?- COULD YOU PLEASE PROVIDE THE LOT NUMBER?=>UNK- PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS:=>HIROMI TOKUYAMA NO PRODUCT IS AVAILABLE FOR RETURN.THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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.