VALLEYLAB
Report
- Report Number
- 1717344-2025-01588
- Event Type
- Malfunction
- Date Received
- December 11, 2025
- Date of Event
- November 13, 2025
- Report Date
- February 19, 2026
- Manufacturer
- COVIDIEN
- Product Code
- GEI
- UDI-DI
- 10884521516328
- PMA / PMN Number
- K151649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. EVALUATION IDENTIFIED ERRORS 320 AND 322 IN THE MEMORY LOGS. ERROR 320 INDICATES THAT THE MONOPOLAR 1 HANDLE WAS DEPRESSED DURING STARTUP, AND ERROR 322 INDICATES THAT THE MONOPOLAR 2 HANDLE WAS DEPRESSED DURING STARTUP. THE CUTTING FUNCTION APPEARS TO HAVE BEEN ACTIVATED DUE TO INADVERTENT ACTIVATION OF THE CART FOOTSWITCH AND DOES NOT REQUIRE TECHNICAL ACTION. THE ISSUE WAS RESOLVED BY REPLACING THE DISPLAY ASSEMBLY AND THE FLEX LADDER CABLE. IT WAS REPORTED THAT WHEN THE UNIT¿S BIPOLAR MODE WAS TURNED ON, A MESSAGE INDICATED THAT CALIBRATION COULD NOT BE COMPLETED, AND THE ELECTRIC POCKET KNIFE MODE ACTIVATED AUTOMATICALLY. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE EVALUATION DETECTED AN UNREPORTED CONDITION: THE SCREEN COULD NOT BE CALIBRATED, AND ERROR CODES 213, 233, 308, 336, 346, AND 347 WERE RECORDED. THE MOST LIKELY CAUSE FOR THE ADDITIONAL CONDITION WAS TRACED TO COMPONENT FAILURE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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.
ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND ERROR CODES 320 AND 322 IN THE MEMORY LOGS. ERROR 320 INDICATES THAT THE MONOPOLAR 1 HANDLE WAS PRESSED DURING STARTUP, AND ERROR 322 INDICATES THAT THE MONOPOLAR 2 HANDLE WAS PRESSED DURING STARTUP. THE CUTTING FUNCTION APPEARS TO HAVE BEEN ACTIVATED BY PRESSING THE FOOTSWITCH ON THE CART AND DOES NOT REQUIRE TECHNICAL ACTION. THE SCREEN COULD NOT BE CALIBRATED. THE ISSUE WAS RESOLVED BY REPLACING THE DISPLAY ASSEMBLY AND THE FLEX LADDER CABLE. IT WAS REPORTED THAT WHEN THE UNIT¿S BIPOLAR WAS TURNED ON, A MESSAGE APPEARED STATING THAT THE CALIBRATION COULD NOT BE COMPLETED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO A COMPONENT FAILURE. IT WAS ALSO REPORTED THAT THE ELECTRIC POCKET KNIFE MODE STARTED WORKING ON ITS OWN. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE EVALUATION DETECTED AN UNREPORTED CONDITION: ERROR CODES 213 (SYSTEM ERROR), 233 (CONFIGURATION MISMATCH), 308 (INTERNAL CHECK), 336 (INTERNAL CHECK), 346 (INTERNAL CHECK), AND 347 (INTERNAL CHECK). THE MOST LIKELY CAUSE FOR THE ADDITIONAL CONDITION WAS TRACED TO A COMPONENT FAILURE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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.
IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE UNIT'S BIPOLAR WAS TURNED ON, IT GAVE A MESSAGE THAT THE CALIBRATION COULD NOT BE FINISHED AND THE ELECTRIC POCKET KNIFE MODE STARTED WORKING ON ITS OWN. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2604221 | VALLEYLAB | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | COVIDIEN | VLFT10GEN | 10884521516328 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |