BIZACT
Report
- Report Number
- 1717344-2024-01155
- Event Type
- Malfunction
- Date Received
- May 17, 2024
- Date of Event
- April 18, 2024
- Report Date
- July 18, 2024
- Manufacturer
- COVIDIEN MFG DC BOULDER
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PLEASE NOTE THAT THE INVOLVED DEVICE IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE BIZACT GEI. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THERE WERE AN ISSUE WITH ALARM ACTIVATION, KNIFE BLADE DID NOT ADVANCE AND NO SEAL. THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
D10 CONCOMITANT PRODUCT: VLFT10GEN, VLFT10GEN FT SERIES ENERGY PLATFORMX1, (SN #UNKNOWN) THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K171066. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE STARTED-UP AND END SOUNDS WERE HEARD, BUT SEALING WAS INSUFFICIENT/PARTIAL. ALTHOUGH THERE WAS A SEALING SOUND, THERE WAS NO SIGN OF SEALING (EVAPORATION SOUND OR WATER VAPOR), AND THE CUTTER DID NOT ADVANCE AND EVEN WHEN JAWS WERE OPENED AND TISSUES WERE OBSERVED, BUT THERE WAS NO SENSATION OF SEALING BEING DONE. UPON ATTEMPTING SEVERAL TIMES, THE SITUATION WAS THE SAME, SO SAFETY WAS CONSIDERED AND REPLACED WITH A NEW PRODUCT WHICH SEALED WITHOUT ANY PROBLEMS, SO THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.
ACCORDING TO THE REPORTER, DURING MASTECTOMY, THE DEVICE STARTED-UP, END SOUNDS WERE HEARD AND REGRASP ALERT OF SEALING NOT COMPLETED. ALTHOUGH THERE WAS A SEALING SOUND, THERE WAS NO SIGN OF SEALING (EVAPORATION SOUND OR WATER VAPOR), AND THE CUTTER DID NOT ADVANCE EVEN WHEN JAWS WERE OPENED AND TISSUES WAS OBSERVED, BUT THERE WAS NO SENSATION OF SEALING BEING DONE. UPON ATTEMPTING SEVERAL TIMES, THE SITUATION WAS THE SAME, SO SAFETY WAS CONSIDERED AND REPLACED WITH A NEW PRODUCT WHICH SEALED WITHOUT ANY PROBLEMS, SO THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 904856 | BIZACT | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | COVIDIEN MFG DC BOULDER | BZ4212 | 32550207X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SEE H11 |