1" BLADE ELECTRODE
Report
- Report Number
- 1060680-2017-00009
- Event Type
- Malfunction
- Date Received
- March 2, 2017
- Date of Event
- January 24, 2017
- Report Date
- March 21, 2017
- Manufacturer
- MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
- Product Code
- HGI
- PMA / PMN Number
- K952030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ROOT CAUSE: THE ELECTRODE IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO (B)(4). IN ITS RESPONSE, (B)(4) REVIEW AND TESTED RETAINED SAMPLES AND OBSERVED NO MELTING ON THE INSULATED TUBE OR ELECTRODE TIP. THEREFORE, THE ROOT CAUSE IS UNABLE TO BE DETERMINED. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) STATED IF THE DEFECTIVE SAMPLES OR ADDITIONAL INFORMATION IS RECEIVED, FURTHER ANALYSIS WILL BE TAKEN. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING A 1" BLADE ELECTRODE MELTED DURING USE. NO PATIENT HARM WAS REPORTED. ON FEBRUARY 23, 2017, DEROYAL RECEIVED NOTICE OF A MEDWATCH REPORT FROM THE FDA. THIS MEDWATCH REPORT IS RELATED TO THE INCIDENT REPORTED IN 1060680-2017-00008. DURING A REVIEW OF COMPLAINTS, THIS REPORT WAS FOUND TO BE RELATED. A SAMPLE INITIALLY WAS REPORTED TO BE AVAILABLE. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RECEIVED. A DEROYAL SALES REPRESENTATIVE HAS BEEN IN CONTACT WITH THE REPORTING CUSTOMER, AND IF THE SAMPLE IS RECEIVED, THE COMPLAINT INVESTIGATION WILL BE REOPENED. THE WORK ORDER FOR THE REPORTED LOT NUMBER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. A SCAR WAS ISSUED TO (B)(4) AND A RESPONSE RECEIVED MARCH 3. DEROYAL QUALITY PERSONNEL HAS REVIEWED AND ACCEPTED THE RESPONSE. IN ITS RESPONSE, (B)(4) STATED FOUR SAMPLES FROM TWO LOTS WERE TESTED USING A BOVIE GENERATOR AT POWER SETTING 40 FOR 10 CYCLES (ONE CYCLE IS 10 SECONDS FOR CUT MODE AND 10 SECONDS FOR COAGULATION MODE). ALL SAMPLES PASSED WITHOUT ANY MELTING OCCURRING ON THE INSULATED TUBE OR THE ELECTRODE TIP. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING A 1" BLADE ELECTRODE MELTED DURING USE. NO PATIENT HARM WAS REPORTED. ON FEBRUARY 23, 2017, DEROYAL RECEIVED NOTICE OF A MEDWATCH REPORT FROM THE FDA. THIS MEDWATCH IS RELATED TO THE INCIDENT REPORTED IN 1060680-2017-00008. DURING A REVIEW OF COMPLAINTS, THIS REPORT WAS FOUND TO BE RELATED. A SAMPLE INITIALLY WAS REPORTED TO BE AVAILABLE. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RECEIVED. THE ELECTRODE IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS SUBMITTED FEBRUARY 22, 2017, TO MODERN MEDICAL. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THIS REPORT HAS NOT BEEN SUBMITTED WITHIN THE 30 DAYS REQUIRED. THIS IS DUE TO AN EMPLOYEE ERROR. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
INSULATED COATED ELECTRODE BLADES MELTED DURING USE. THE SETTINGS WERE SET AT COAG 40/CUT 40. THERE WAS NO APPARENT HARM TO THE PATIENT. THE DEVICE WAS IN USE WITH A CAUTERY MACHINE.
INSULATED COATED ELECTRODE BLADES MELTED DURING USE. THE SETTINGS WERE SET AT COAG 40/CUT 40. THERE WAS NO APPARENT HARM TO THE PATIENT. THE DEVICE WAS IN USE WITH A CAUTERY MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155676 | 1" BLADE ELECTRODE | ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) | HGI | MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. | 88-000M13C | 41057548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |