VISTASEAL DUAL APPLICATOR
Report
- Report Number
- 2210968-2022-02350
- Event Type
- Malfunction
- Date Received
- April 4, 2022
- Date of Event
- January 1, 2022
- Report Date
- July 25, 2022
- Manufacturer
- ETHICON INC.
- Product Code
- MZM
- UDI-DI
- 10705031462533
- PMA / PMN Number
- BK180287
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 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? NO IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? HUNDREDS. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? HUNDREDS. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? NO. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? THE DEVICE IS BEING SENT BACK. IS THE DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION? YES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE POSSIBLE FINISHED DEVICE LOTS, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION: D4, H4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: 2648698 & 2672904. BATCH 2648698 MFG DATE: JUNE 9, 2020, EXP DATE: JUNE 10, 2023. BATCH 2672904 MFG DATE: AUGUST 3, 2020, EXP DATE: AUGUST 05, 2023. 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.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D9 - DATE DEVICE RETURNED TO MANUFACTURER, D9. IS DEVICE RETURNED TO MANUFACTURER? 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. CORRECTED INFORMATION: D9 - DEVICE AVAILABLE FOR EVALUATION?
PRODUCT COMPLAINT # ==> (B)(4) ADDITIONAL INFORMATION: D4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: 2648698 & 2672904 ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE TIP LOTS USED IN B4YDF00381 ARE 2648698 & 2672904 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.
PRODUCT COMPLAINT # ==> (B)(4). ADDITIONAL INFORMATION: D9. IS DEVICE RETURNED TO MANUFACTURER?. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE VSTAS1 DEVICE WAS RETURNED WITH DAMAGED IN THE LUER LOCKS. IN ADDITION, THE PRE-FILLED SYRINGE WAS FILLED WITH WATER. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY FUNCTIONAL ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY TESTED, AND THE LUERS MOVE CORRECTLY AND CAN BE BOTH TIGHTENED AND LOOSENED WITHOUT ISSUES OBSERVED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. 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. CORRECTED INFORMATION: H3, H6. COMPONENT CODE, H6. TYPE OF INVESTIGATION, H 6. INVESTIGATION CONCLUSIONS.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE THEY COULD NOT GET THE LURE LOCKS TO LOOSEN IN ORDER TO PUT THE LAPAROSCOPIC APPLICATOR ON. A NEW UNIT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 81873 | VISTASEAL DUAL APPLICATOR | FIBRIN SEALANT PREPARATION DEVICE | MZM | ETHICON INC. | VSTAS1 | 10705031462533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |