SINGLE USE ELECTROSURGICAL KNIFE KD-655
Report
- Report Number
- 9614641-2025-01642
- Event Type
- Malfunction
- Date Received
- October 1, 2025
- Date of Event
- August 29, 2025
- Report Date
- October 24, 2025
- Manufacturer
- AOMORI OLYMPUS CO., LTD.
- Product Code
- KNS
- PMA / PMN Number
- K171158
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: - BLACK FOREIGN MATERIAL WAS ATTACHED TO THE DISTAL END COVER. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: 1) DUE TO THE FACTOR DESCRIBED BELOW, AN ELECTRICAL DISCHARGE OCCURRED BETWEEN THE TISSUE AND THE CUTTING KNIFE DURING OUTPUT ACTIVATION. ·THE OUTPUT SETTING FOR ACTIVATION WAS TOO HIGH ·THE ELECTROSURGICAL UNIT WAS USED IN THE COAGULATION MODE. ·THE OUTPUT ACTIVATION TIME WAS TOO LONG. 2) THE ELECTRICAL DISCHARGE OCCURRED, CAUSING THE PART OF THE CUTTING KNIFE TO BECOME INSTANTLY HOT. AS A RESULT, THE STRENGTH OF THE CUTTING KNIFE DECREASED. 3) DURING TISSUE INCISION, A LOAD WAS APPLIED TO THE CUTTING KNIFE, WHICH HAD REDUCED STRENGTH. THIS LIKELY CAUSED THE CUTTING KNIFE TO BREAK. HOWEVER, THE EXACT CAUSE OF THE ELECTRICAL DISCHARGE GENERATION COULD NOT BE IDENTIFIED. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: DRAWING NUMBER AND REVISION NUMBER OF IFU: GK9212 08 USE THIS INSTRUMENT ONLY IN COMBINATION WITH PRODUCTS RECOMMENDED BY OLYMPUS. IF COMBINED WITH PRODUCTS NOT RECOMMENDED BY OLYMPUS, PATIENT INJURY CAUSED BY INCREASE IN PATIENT LEAKAGE CURRENT, OPERATOR INJURY, MALFUNCTION OR EQUIPMENT DAMAGE MAY RESULT. 8.2 SPECIFICATIONS DURING TREATMENT, ALWAYS ENSURE THAT THE SLIDER SLIDES ON THE HANDLE SMOOTHLY AND THAT THE ELECTROSURGICAL KNIFE OBSERVED IN THE ENDOSCOPIC IMAGE IS NORMAL. SHOULD DEFORMATION OR BREAK OF THE CUTTING KNIFE BE DETECTED DURING USE, IMMEDIATELY SHUT OFF THE POWER SUPPLY, DISCONTINUE THE PROCEDURE, PULL THE SLIDER AND WITHDRAW THE ENDOSCOPE FROM THE PATIENT WITH THE CUTTING KNIFE RETREATED IN THE COATED OUTER TUBE. DO NOT CONTINUE USING AN ABNORMAL ELECTROSURGICAL KNIFE TO PREVENT PERFORATION OR BLEEDING. IF THE CUTTING KNIFE IS DETACHED, BE SURE TO COLLECT IT USING A GRASPING FORCEPS. ALWAYS OPERATE THE ELECTROSURGICAL UNIT AT THE MINIMUM OUTPUT LEVEL AND FOR THE MINIMUM TIME NECESSARY TO SUCCESSFULLY COMPLETE THE PROCEDURES. AN EXCESSIVE OUTPUT LEVEL AND TIME MAY RESULT IN PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. APPLICATION OF HIGH-VOLTAGE WAVEFORMS FOR EXTENDED PERIODS INCREASES THE LIKELIHOOD THAT THE CUTTING KNIFE MAY BREAK. WHEN A HIGH-VOLTAGE WAVEFORM HAS TO BE USED, MINIMIZE THE DURATION OF CURRENT APPLICATION. ¿ ELECTROSURGICAL UNIT: VOLTAGE INTENSITIES OF VARIOUS WAVEFORMS SOFT COAGULATION < CUT / PULSE CUT < FORCED COAGULATION IF THE CUTTING KNIFE IS USED IN A HIGH-HUMIDITY SITUATION, IT MAY BE DAMAGED BY MELTING OR ELONGATION. DO NOT USE THIS INSTRUMENT WITH BURNT TISSUE ADHERING TO THE CUTTING KNIFE OR TIP. USE THE INSTRUMENT AFTER REMOVING THE BURNT TISSUE ADHERING WITH A LINT-FREE CLOTH. BE CAREFUL NOT TO USE EXCESSIVE FORCE WHEN REMOVING TISSUE ATTACHED TO THE CUTTING KNIFE. WHEN THE DISTAL END IS SUBJECTED TO EXCESSIVE FORCE, FOR EXAMPLE, WHEN FORCIBLY SCRAPING THE CUTTING KNIFE WITH TWEEZERS, ETC. OR WHEN EXTENDING AND RETRACTING THE CUTTING KNIFE ABRUPTLY AND CONTINUOUSLY, IT MAY BREAK THE CUTTING KNIFE. REFERENCE CURRENT OUTPUT LEVELS IN COMBINATION WITH OLYMPUS ELECTROSURGICAL UNIT ESG-100 THE HIGH-FREQUENCY WAVEFORMS PROVIDED IN THE TABLE ARE STANDARD CURRENT OUTPUT LEVELS, WHICH ARE USED IN THE MOST COMMON CASES TO THE BEST KNOWLEDGE OF OLYMPUS. WHEN YOU OPERATE THE ELECTROSURGICAL UNIT, ALWAYS SET AN APPROPRIATE OUTPUT LEVEL ACCORDING TO THE FOLLOWING CONDITIONS: -THE CONDITION OF TISSUE TO BE CUT OR COAGULATED -THE TYPE/CONFIGURATION/RATED HIGH-FREQUENCY VOLTAGE OF THE DEVICE THAT YOU USE -THE CONTACT AREA (LENGTH) BETWEEN THE ELECTRODE AND THE TISSUE -OPERATIONAL CONDITIONS LIKE USE OF INJECTION SOLUTION, AND SO ON -YOUR THERAPEUTIC STRATEGY (WHETHER YOU PUT A PRIORITY ON THE PREVENTION OF BLEEDING OR ON LIMITING THERMAL INJURY TO SURROUNDING TISSUE). IF ANY DEBRIS OR TISSUE IS ATTACHED TO THE CUTTING KNIFE, MOVE THE SLIDER BACK AND FORTH TO EXTEND AND RETRACT THE CUTTING KNIFE WHILE THE STERILE FLUID IS BEING SUPPLIED. DOING SO MAY FACILITATE THE REMOVAL OF THE DEBRIS OR TISSUE. IF THE DEBRIS OR TISSUE IS STILL ATTACHED TO THE CUTTING KNIFE, WITHDRAW THIS ELECTROSURGICAL KNIFE FROM THE ENDOSCOPE FOR WIPING THE DEBRIS OR TISSUE AWAY WITH LINT-FREE CLOTHS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTED INFORMATION. CORRECTED FIELDS: D4.
IT WAS REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE EXHIBITED THE KNIFE HEAD WAS FRACTURED. IN TURN, WHEN REMOVING FROM THE BODY FOR FLUSHING AND WIPING, THE KNIFE HEAD FELL OFF. THE UNSPECIFIED PROCEDURE WAS PROLONGED GREATER THAN OR EQUAL TO 30 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2014580 | SINGLE USE ELECTROSURGICAL KNIFE KD-655 | SINGLE USE ELECTROSURGICAL KNIFE | KNS | AOMORI OLYMPUS CO., LTD. | KD-655U | 37K20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |