VISTASEAL DUAL APPLICATOR
Report
- Report Number
- 2210968-2024-00147
- Event Type
- Malfunction
- Date Received
- January 5, 2024
- Date of Event
- January 3, 2024
- Report Date
- March 5, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- MZM
- UDI-DI
- 10705031462533
- PMA / PMN Number
- BK180287
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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: 3252070 AND 3278652. 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. CORRECTED INFORMATION: H6. MEDICAL DEVICE PROBLEM CODE.
PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. INVESTIGATION SUMMARY : THE PRODUCT WAS RETURNED TO ETHICON 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 OF THROMBIN EMPTY AND THE PRE-FILLED SYRINGE OF FIBRINOGEN FILL. 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. AS PART OF ETHICON¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. PER INSTRUCTIONS FOR USE: ¿LOOSEN THE LUER LOCKS TO REMOVE THE SPRAY AND DRIP TIP FROM THE ADAPTER, ATTACH THE VISTASEAL LAPAROSCOPIC DUAL APPLICATOR TO THE ADAPTER BY TIGHTENING THE LUER LOCK¿. 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.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE POSSIBLE FINISHED DEVICE LOTS, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: BATCH 3252070: MFG DATE: 09/23/2022, EXP DATE: 09/24/2027. BATCH 3278652: MFG DATE: 11/05/2022, EXP DATE: 11/06/2027. 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.
PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED 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: 1. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? NO. 2. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO. 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.
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2024 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE FLEXIBLE TIP WOULDN'T COME OFF DURING A PROCEDURE. THE SURGEON HAD THE LAPAROSCOPIC ATTACHMENT SUCCESSFULLY ON LIVER BED. ANOTHER FIBRIN SEALANT PREPARATION DEVICE WAS USED AFTER BEING THAWED IN WARM WATER, BUT THE SCRUB TECH COULD NOT UNSCREW LOWER LOCKS. THE SURGEON ATTEMPTED TO UNSCREW WITH HEMOSTAT AND THAT DID NOT WORK. THE SALES REPRESENTATIVE ENTERED THE ROOM AND CONFIRMED THEY WERE TURNING SCREWS IN THE RIGHT DIRECTION. THE SURGEON GOT ANOTHER FIBRIN SEALANT PREPARATION DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 676168 | VISTASEAL DUAL APPLICATOR | FIBRIN SEALANT PREPARATION DEVICE | MZM | ETHICON INC. | A04H076841 | 10705031462533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |