VISTASEAL DUAL APPLICATOR
Report
- Report Number
- 2210968-2025-08444
- Event Type
- Malfunction
- Date Received
- July 22, 2025
- Date of Event
- July 10, 2025
- Report Date
- September 23, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- MZM
- UDI-DI
- 10705031462533
- PMA / PMN Number
- BK180287
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. IS THE USER A NEW USER TO VISTASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? NO, HAVE USED AT LEAST 10 TIMES AT THIS FACILITY. 2. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? AT LEAST 10 TIMES. 3. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? NO. 4. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? NO. 5. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO. 6. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? NO. 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). D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED. 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: 3371989 AND 3333946. BATCH 3371989 MFG DATE: 6/10/2023, EXP DATE: 6/10/2028, BATCH 3333946 MFG DATE: 2/21/2023, EXP DATE: 2/24/2028. 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). CORRECTED INFORMATION: D 9. DEVICE AVAILABLE FOR EVALUATION? ADDITIONAL INFORMATION: D 9. DATE DEVICE RETURNED TO MANUFACTURER, D 9. IS DEVICE RETURNED TO MANUFACTURER?, H 6. COMPONENT CODE, H 6. TYPE OF INVESTIGATION, H 6. INVESTIGATION FINDINGS, H 6. INVESTIGATION CONCLUSIONS. H6 COMPONENT CODE: G07002 - PENDING EVALUATION OF RETURNED DEVICE. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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). CORRECTED INFORMATION: H 3. DEVICE EVALUATED BY MANUFACTURER? ADDITIONAL INFORMATION: H 6. COMPONENT CODE, H 6. TYPE OF INVESTIGATION, H 6. INVESTIGATION FINDINGS, H 6. INVESTIGATION CONCLUSIONS. 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 SYRINGES STILL WITH COMPONENT. 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. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. 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¿. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. ADDITIONAL INFORMATION: LNSTITUTO GRIFOLS, S.A. (IG) RECEIVED A NOTIFICATION THROUGH ETHICON RELATED TO ONE UNIT OF VISTASEAL 4ML, BATCH NUMBER A04J035041, REPORTING THAT "THE SURGICAL TECH WAS UNABLE TO UNSCREW THE GRAY LUER LOCKS TO REMOVE THE OPEN APPLICATOR BEFORE ATTACHING THE LAPAROSCOPIC APPLICATOR. THEY HAD ALREADY USED ONE 4ML OF VISTASEAL WITH A LAP APPLICATOR ON THE CASE SO THE SURGEON DETERMINED THEY WEREN'T GOING TO USE THE SECOND 4ML OF VISTASEAL AFTER HAVING TROUBLE DISCONNECTING THE OPEN APPLICATOR." THERE WERE NO PATIENT CONSEQUENCES REPORTED. UPON THE RECEPTION OF THE REPORTED INCIDENT, ADDITIONAL INFORMATION WAS REQUESTED TO SUPPORT THE INVESTIGATION, INCLUDING THE EXPERIENCE OF THE USER WITH THE PRODUCT, THE PRESENCE OF ANY LEAKAGE OBSERVED AT THE CONNECTION, AS WELL AS THE AVAILABILITY OF PICTURES/SAMPLE OF THE DEVICE INVOLVED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE USER HAD EXTENSIVE EXPERIENCE WITH THE PRODUCT. NO LEAKAGE WAS OBSERVED. THERE WERE NO PICTURES OF THE DEVICE INVOLVED. THE DEVICE WAS RECEIVED AT THE ETHICON FACILITIES, AND THE SUBSEQUENT INVESTIGATION INDICATED THE FOLLOWING: A. EVALUATION OF THE RETURNED SAMPLE AT ETHICON FACILITIES: VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE DEVICE WAS RETURNED WITH DAMAGE IN THE LUER LOCKS AND THE PRE-FILLED SYRINGES STILL WITH COMPONENT. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY FUNCTIONAL ISSUES. UPON EVALUATION OF THE DEVICE, THE LUERS MOVED CORRECTLY AND COULD 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. ACCORDING TO ETHICON'S INVESTIGATION NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. ACCORDING TO OUR STANDARD PROCEDURES, IG INITIATED AN INVESTIGATION FOCUSED ON: B. INVESTIGATION OF THE DUAL APPLICATOR TIP. CONSIDERING THE NATURE OF THE REPORTED INCIDENT, IG REQUESTED ETHICON, AS THE SUPPLIER OF VISTASEAL DUAL APPLICATOR, TO INVESTIGATE THE BATCH OF TIPS INVOLVED. THE INVESTIGATION FOCUSED ON REVIEWING THE BATCH RECORDS FOR THE BATCH OF TIPS USED. ETHICON CONCLUDED THAT ALL COMPONENTS USED IN THE BATCH INVOLVED MET THE ESTABLISHED SPECIFICATIONS, WITH NO RELATED INCIDENTS REPORTED. C. RESULTS OF QUALITY CONTROL PERFORMED AT IG FACILITIES: ACCORDING TO IG STANDARD PROCEDURES, THE RESULTS OF THE QUALITY CONTROLS PERFORMED TO THE INCOMING MATERIALS (TIPS) INVOLVED IN THE NOTIFICATION WERE REVIEWED. A REVIEW OF THE RESULTS RELATED TO THE LUER LOCKS FUNCTIONALITY PERFORMED TO INCOMING TIPS KITTED WITH THE INVOLVED BATCH, A04J035041, WAS PERFORMED. THE RESULTS WERE FOUND CORRECT, AND NO DEVIATIONS WERE DETECTED. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED, THE ABSENCE OF ANY ANOMALIES DURING THE MANUFACTURING PROCESS OF THE TIPS, ALONG WITH COMPLIANT RESULTS FROM THE INCOMING INSPECTION, SUPPORTS THE CONCLUSION THAT THE REPORTED ISSUE IS NOT RELATED TO THE QUALITY OF THE COMPONENTS USED. THEREFORE, IG WOULD LIKE TO EMPHASIZE THE IMPORTANCE OF STRICTLY FOLLOWING THE INSTRUCTIONS PROVIDED IN THE PRODUCT LEAFLET, PARTICULARLY THE FOLLOWING INDICATION: DO NOT USE ANY EXTERNAL ELEMENT OR TOOL TO DISSEMBLE THE TIPS AND UNSCREW THE LUER LOCKS MANUALLY. TO RECORD THE REPORTED INCIDENT RELATED TO THE DUAL APPLICATOR, IG WILL TRACK IT IN THEIR SYSTEM FOR MONITORING WITH THE SUPPLIER OF THE RELATED TIPS. 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). 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: -ACTION TAKEN WHEN EVENT OCCURRED? --> DECIDED NOT TO USE THE PRODUCT, -WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, -PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: -WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN, -WERE FRAGMENTS GENERATED? --> UNKNOWN, -IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, -WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, -IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN. 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. 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? 4. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? 5. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? 6. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? ADDITIONAL INFORMATION: D4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: 3371989 AND 3333946. 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.
IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE SURGICAL TECH WAS UNABLE TO UNSCREW THE GRAY LUER LOCKS TO REMOVE THE OPEN APPLICATOR BEFORE ATTACHING THE LAPAROSCOPIC APPLICATOR. THEY HAD ALREADY USED ONE 4ML OF FIBRIN SEALANT PREPARATION DEVICE WITH A LAP APPLICATOR ON THE CASE SO THE SURGEON DETERMINED THEY WEREN¿T GOING TO USE THE SECOND 4ML OF FIBRIN SEALANT PREPARATION DEVICE AFTER HAVING TROUBLE DISCONNECTING THE OPEN APPLICATOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2293759 | VISTASEAL DUAL APPLICATOR | FIBRIN SEALANT PREPARATION DEVICE | MZM | ETHICON INC. | 10705031462533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |