VISTASEAL DUAL APPLICATOR
Report
- Report Number
- 2210968-2026-00046
- Event Type
- Malfunction
- Date Received
- January 5, 2026
- Date of Event
- December 26, 2025
- Report Date
- March 13, 2026
- Manufacturer
- ETHICON INC.
- Product Code
- MZM
- PMA / PMN Number
- BK180287
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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?, H6. 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. ADDITIONAL INFORMATION: D4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: 3634821 AND 3632118. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. DID NOT USE DEFECT LURE LOCK PIECE. GOT A NEW OPEN TIP FOR CONNECTOR TO LAP TIP. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO. 2. 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). ADDITIONAL INFORMATION: H6. ADDITIONAL INFORMATION: D4, H4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: BATCH 3632118 MFG DATE: 01/07/2025, EXP DATE: 01/08/2030. BATCH 3634821 MFG DATE: 01/11/2025, EXP DATE: 01/11/2030 . 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 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: WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO. 1. IS THE USER A NEW USER TO VISTASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? YES, FIRST TIME TECHNICIAN. 2. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? FIRST TIME. 3. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? REP WAS IN CASE PROVIDING INSTRUCTIONS WITH DEMO DEVICE AND IS EXPERIENCED WITH LAP TIP PREP OF DEVICE. 4. PLEASE CLARIFY, WHICH COMPONENT BROKE (THE VISTASEAL APPLICATOR OR THE LAPAROSCOPIC APPLICATOR)? THE CONNECTOR OR ¿WHITE HAT¿ WHICH IS NECESSARY TO CONNECT OPEN TIP AND OR LAP TIPS. THE INNER PIECE OF THE OPEN TIP BROKE OFF AND REMAINED IN GREY LURE LOCK NOT ALLOWING LAP TIP TO BE SECURED VIA LURE LOCK. 5. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? DID NOT USE DEFECT LURE LOCK PIECE. GOT A NEW OPEN TIP FOR CONNECTOR TO LAP TIP. 6. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO 7. 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). CORRECTED INFORMATION: H3. DEVICE EVALUATED BY MANUFACTURER? ADDITIONAL INFORMATION: H 6. COMPONENT CODE, H 6. TYPE OF INVESTIGATION, H 6. INVESTIGATION FINDINGS, H 6. INVESTIGATION CONCLUSIONS. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETH FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONLY THE SPRAY AND DRIP TIP FROM THE VSTAS1 DEVICE WAS RETURNED WITH ONE SIDE DAMAGED. IN ADDITION, THE SECONDARY BOX WAS RETURNED ALONG WITH THE INSTRUMENT. 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, THE SPRAY AND DRIP TIP COULD NOT REMOVE FROM THE ADAPTER DUE TO THE DAMAGE ON IT. AS PART OF ETH 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 WAS CONFIRMED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. ADDITIONAL INFORMATION: LNSTITUTO GRIFOLS, S.A. (IG) UPON RECEIPT OF THE REPORTED INCIDENT, ADDITIONAL INFORMATION WAS REQUESTED TO SUPPORT THE INVESTIGATION, INCLUDING THE BATCH NUMBER, DETAILS REGARDING THE USER'S PRIOR EXPERIENCE WITH VISTASEAL AND USE OF THE LAPAROSCOPIC TIP, THE PRESENCE OF A SALES REPRESENTATIVE DURING THE PROCEDURE, CLARIFICATION ON WHICH COMPONENT HAD BROKEN, WHETHER ANY LEAKAGE WAS OBSERVED AT THE LUER LOCK CONNECTION, WHETHER ANY UNEXPECTED OUTCOMES OR COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT, AND THE AVAILABILITY OF IMAGES OF THE DAMAGED DEVICE. TO DATE, THE DEVICE HAS BEEN RETURNED TO ETHICON FACILITIES, AND THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE BATCH NUMBER OF THE AFFECTED DEVICE IS A04K071491. THE USER WAS A FIRST-TIME TECHNICIAN, AND THIS WAS ALSO THEIR FIRST USE OF THE LAPAROSCOPIC TIP. A SALES REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE, PROVIDING INSTRUCTIONS WITH A DEMO DEVICE AND WAS EXPERIENCED IN LAPAROSCOPIC TIP PREPARATION. THE COMPONENT THAT BROKE WAS THE CONNECTOR OR "WHITE HAT"; THE INNER PIECE OF THE OPEN TIP DETACHED AND REMAINED INSIDE THE GREY LUER LOCK, PREVENTING SECURE ATTACHMENT OF THE LAPAROSCOPIC TIP. NO LEAKAGE WAS OBSERVED, AS THE DEFECTIVE LUER LOCK COMPONENT WAS NOT USED AND A NEW OPEN TIP WAS OBTAINED. NO UNEXPECTED OUTCOMES OR COMPLICATIONS RESULTED FROM THE EVENT. NO IMAGES OF THE DAMAGED DEVICE ARE AVAILABLE. ACCORDING TO OUR STANDARD PROCEDURES, AN INVESTIGATION WAS INITIATED FOCUSED ON THE FOLLOWING: EVALUATION OF THE RETURNED SAMPLE AT ETHICON FACILITIES. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONLY THE SPRAY AND DRIP TIP WAS RETURNED WITH ONE SIDE DAMAGED (FIGURE 1). IN ADDITION, THE SECONDARY BOX WAS RETURNED ALONG WITH THE INSTRUMENT. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY FUNCTIONAL ISSUES. UPON EVALUATION OF THE DEVICE, THE SPRAY AND DRIP TIP COULD NOT BE REMOVED FROM THE ADAPTER DUE TO THE DAMAGE ON IT. 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 WAS CONFIRMED. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA: SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. 2) INVESTIGATION OF THE DUAL APPLICATOR TIP. CONSIDERING THE NATURE OF THE REPORTED INCIDENT, ETHICON, AS SUPPLIER OF THE VISTASEAL DUAL APPLICATOR, WAS REQUESTED TO INVESTIGATE THE BATCHES OF THE TIPS INVOLVED. THE INVESTIGATION FOCUSED ON REVIEWING THE RESULTS OF BATCH RECORDS FOR THE BATCHES OF TIPS USED. IT WAS CONCLUDED THAT ALL THE COMPONENTS' PARTS UTILIZED FOR THE BATCH INVOLVED MET THE ESTABLISHED SPECIFICATIONS WITH NO INCIDENTS RELATED. 3) RESULTS OF QUALITY CONTROL PERFORMED AT IG FACILITIES: LNSTITUTO GRIFOLS, S.A. REVIEWED THE RESULTS OF THE QUALITY CONTROLS PERFORMED TO THE INCOMING MATERIALS (TIPS) INVOLVED IN THE NOTIFICATION, ESPECIALLY THOSE RELATED TO LUER LOCK FUNCTIONALITY PERFORMED TO INCOMING TIPS KITTED WITH THE INVOLVED BATCH, A04K071491 . THE RESULTS WERE FOUND CORRECT WITHIN SPECIFICATIONS AND NO DEVIATIONS WERE DETECTED. ALTHOUGH NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS NOTIFICATION, THE INVESTIGATION PERFORMED, INCLUDING THE EVALUATION OF THE RETURNED DEVICE, SUPPORTS THE CONCLUSION THAT THE REPORTED INCIDENT IS NOT RELATED TO THE QUALITY OF THE PRODUCT OR ITS COMPONENTS USED. BASED ON OUR EXPERIENCE WITH SIMILAR CASES, IG WOULD LIKE TO EMPHASIZE THE IMPORTANCE OF STRICTLY FOLLOWING THE LEAFLET INSTRUCTIONS AND EMPHASIZE THE FOLLOWING INDICATION: DO NOT USE ANY EXTERNAL ELEMENT OR TOOL TO DISSEMBLE THE TIPS AND UNSCREW THE LUER LOCKS MANUALLY. 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 THORACIC ROBOTIC RIGHT MIDDLE WEDGE RESECTION PROCEDURE ON (B)(6) 2025 AND HEMOSTATIC AGENT DUAL APPLICATOR DEVICE WAS USED. THE OPEN TIP DID NOT FUNCTION CORRECTLY WHEN IT WAS BEING PREPPED FOR THE 45CM LAP TIP TO BE PLACED ON DEVICE FOR PRODUCT USE. GREY LURE LOCKS ON OPEN TIP CONNECTOR DID NOT SCREW OFF AND GOT JAMMED TO WHERE THE PLASTIC THREADING BROKE OFF AND RENDERED THE OPEN TIP USELESS. HAD TO GET ANOTHER DEVICE JUST FOR OPEN TIP SO 45CM LAP TIP COULD BE PLACED FOR PRODUCT USE IN ROBOT CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28848 | VISTASEAL DUAL APPLICATOR | FIBRIN SEALANT PREPARATION DEVICE | MZM | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |