THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
Report
- Report Number
- 8010047-2022-10554
- Event Type
- Malfunction
- Date Received
- June 22, 2022
- Date of Event
- May 22, 2022
- Report Date
- May 3, 2024
- Manufacturer
- AOMORI OLYMPUS CO., LTD.
- Product Code
- GEI
- UDI-DI
- 04953170383540
- PMA / PMN Number
- K211838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CUSTOMER REPORTED FOUR EVENTS OF FAILED THUNDERBEAT DEVICES THAT OCCURRED IN FROM MARCH TO MAY 2022, THE ISSUE BEING PROBE BROKEN OFF. THESE EVENTS ARE CAPTURED IN MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6) (TB-0520FCS, 1JB154), (B)(6) (TB-0535FCS, PW307904), (B)(6) (TB-0535FCS, KR179419), AND (B)(6) (TB-0535FCS, PW307861). THIS MEDWATCH IS FOR THE PATIENT IDENTIFIER (B)(6). THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIVING ADDITIONAL INFORMATION.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED AND AN EVALUATION WAS COMPLETED FOR IT. DURING INSPECTION, OLYMPUS CONFIRMED THE REPORTED EVENT, THE PROBE WAS BROKEN. ADDITIONALLY, THE COATING OF THE GRASPING SECTION WAS PARTIALLY PEELED OFF; HOWEVER, THIS DEFECT IS NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED, THE FOLLOWING STEP-BY-STEP SCENARIO LIKELY CAUSED THE EVENT: 1) DURING THE OUTPUT ACTIVATION IN SEAL & CUT MODE, THE PROBE WAS CONTACTING HARD TISSUE, METAL OBJECTS OR SURGICAL INSTRUMENTS. 2) DUE TO ULTRASONIC VIBRATION, THE COATING OF THE PROBE PEELED OFF. ALSO, SCRATCHES WERE GENERATED. 3) A FORCE TO ACTIVATE THE OUTPUT IN SEAL & CUT MODE, OR A FORCE TO GRASP THE TISSUE WAS APPLIED TO THE PROBE. THEREFORE, CRACKS WERE GENERATED AT THE SCRATCHED AREA. 4) A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. THE FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): ¿THE THUNDERBEAT INSTRUMENT SHOULD BE USED FOR SOFT TISSUE. DO NOT ACTIVATE OUTPUT WHILE GRASPING HARD TISSUE SUCH AS BONE OR HIGHLY CALCIFIED TISSUE, OR HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR, FORCEPS, AND OTHERS). OTHERWISE, IT MAY CAUSE THE PROBE TIP TO BE SCRATCHED OR COME INTO DIRECT CONTACT WITH THE METAL AREA OF THE GRASPING SECTION AS THE HEAT GENERATED BY THE FRICTION BETWEEN THE HARD OBJECT AND THE PROBE TIP COULD CAUSE WEAR/DEFORMING/SPLITTING/PROTRUDING/PARTIAL SEPARATING OF THE TISSUE PAD. IN TURN, THE PROBE MAY BREAK BEFORE DISPLAYING AN ERROR WINDOW OR GENERATING AN ALARM TONE.¿ ¿DO NOT GRASP OR LET THE PROBE TIP CONTACT HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR). ALSO, BE CAREFUL TO AVOID CONTACTING THE PROBE TIP WITH THOSE ACCIDENTALLY. PARTICULARLY DURING ACTIVATION, A SCRATCH ON THE PROBE TIP COULD OCCUR DUE TO ULTRASONIC VIBRATION, WHICH LEADS THE PROBE TIP TO BREAK AND FALL OFF INTO THE BODY CAVITY. IN ADDITION, THE HIGH-FREQUENCY (RF BIPOLAR) CURRENT FLOWS THROUGH THE METAL AND GENERATES SPARK DISCHARGE, WHICH MAY CAUSE BURNS AND DECREASE FUNCTIONALITIES.¿ ¿IF THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT OR THE PROBE TIP GETS STICKED TISSUE DURING TREATMENT, WIPE IT WITH A SOFT OBJECT SUCH AS A PIECE OF GAUZE OR A BRUSH. DO NOT ATTEMPT TO SCRAPE IT WITH A SHARP OBJECT SUCH AS A SCALPEL OR THE TIP OF TWEEZERS. OTHERWISE, THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT, THE FLUORINE RESIN PART, A COATED SURFACE OR THE PROBE TIP MAY BE SCRATCHED AND DAMAGED, WHICH MAY LEAD TO FALL-OFF OF THE DAMAGED PART INTO THE BODY CAVITY OR BURNS OF THE TISSUE BY A HIGH-FREQUENCY LEAK CURRENT OUTPUT DUE TO DESTRUCTION OF THE INSULATION STRUCTURE.¿ OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.
THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED; THEREFORE, THE REPORTED PHENOMENON OR CONDITION OF THE DEVICE COULD NOT BE CONFIRMED. HOWEVER, IT IS POSSIBLE TO INFER THE CAUSE FROM THE RESULTS OF PAST SIMILAR INVESTIGATIONS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE PROBE BROKE DUE TO CONTACT WITH A SURGICAL INSTRUMENT OR THE NON-INSULATED AREA OF GRASPING SECTION. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED, THE FOLLOWING STEP-BY-STEP SCENARIO LIKELY CAUSED THE EVENT: 1. DURING OUTPUT IN SEAL & CUT MODE, THE PROBE CAME IN CONTACT WITH HARD TISSUE, METAL OR A SURGICAL INSTRUMENT. CONSEQUENTLY, A SCRATCH WAS MADE ON THE PROBE. 2. THE PROBE RECEIVED AN OUTPUT LOAD IN SEAL & CUT MODE OR RECEIVED A LOAD WHEN GRASPING TISSUE. AS A RESULT, THE PROBE CRACKED FROM THE SCRATCH. 3. THE PROBE BROKE WHEN ADDED LOAD. OR. 1. THE DISTAL END OF THE TISSUE PAD WAS WORN AWAY BECAUSE ¿SEAL & CUT¿ OUTPUT WAS ACTIVATED WHILE GRASPING NOTHING (INCLUDING THE CASE THE USER KEPT ACTIVATING AFTER CUTTING TISSUE). 2. THE TISSUE PAD WAS WORN AWAY, CAUSING THE NON-INSULATED OF THE GRASPING SECTION TO TOUCH THE PROBE. 3. ¿SEAL & CUT¿ OUTPUT WAS ACTIVATED UNDER THIS SITUATION, THEN THE SCRATCHES INDICATING THAT THE PROBE AND GRASPING SECTION WERE IN CONTACT WITH EACH OTHER WERE MADE. 4. THE PROBE RECEIVED AN OUTPUT LOAD IN SEAL & CUT MODE OR RECEIVED A LOAD WHEN GRASPING TISSUE. AS A RESULT, THE PROBE CRACKED FROM THE SCRATCH. 5. THE PROBE BROKE WHEN ADDED LOAD. THIS FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): ¿DO NOT ACTIVATE OUTPUT IN SEAL & CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL, OR ENSURING THAT TISSUE IS TRANSECTED. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE DUE TO A FRICTION BETWEEN THE PROBE TIP AND THE GRASPING SECTION MAY RESULT IN VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE TISSUE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING.¿ ¿WHEN CUTTING AND VESSEL SEALING IS PERFORMED IN SEAL & CUT MODE, APPLY LIGHT TENSION ON THE TISSUE SO THAT USERS CAN CONFIRM IT IS TRANSECTED. ALSO, STOP ACTIVATION IMMEDIATELY AFTER TISSUE IS TRANSECTED. OTHERWISE, THE GRASPING SECTION, THE TISSUE PAD, OR THE PROBE TIP MAY BREAK AND FALL OFF, AND PARTIAL SEPARATING OF THE TISSUE PAD MAY OCCUR DUE TO A LOCAL INCREASE OF TEMPERATURE CAUSED BY THE FRICTION BETWEEN TISSUE PAD AND THE PROBE TIP DURING ACTIVATION.¿ ¿THE THUNDERBEAT INSTRUMENT SHOULD BE USED FOR SOFT TISSUE. DO NOT ACTIVATE OUTPUT WHILE GRASPING HARD TISSUE SUCH AS BONE OR HIGHLY CALCIFIED TISSUE, OR HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR, FORCEPS, AND OTHERS). OTHERWISE, IT MAY CAUSE THE PROBE TIP TO BE SCRATCHED OR COME INTO DIRECT CONTACT WITH THE METAL AREA OF THE GRASPING SECTION AS THE HEAT GENERATED BY THE FRICTION BETWEEN THE HARD OBJECT AND THE PROBE TIP COULD CAUSE WEAR/DEFORMING/SPLITTING/PROTRUDING/PARTIAL SEPARATING OF THE TISSUE PAD. IN TURN, THE PROBE MAY BREAK BEFORE DISPLAYING AN ERROR WINDOW OR GENERATING AN ALARM TONE.¿ ¿DO NOT GRASP OR LET THE PROBE TIP CONTACT HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR). ALSO, BE CAREFUL TO AVOID CONTACTING THE PROBE TIP WITH THOSE ACCIDENTALLY. PARTICULARLY DURING ACTIVATION, A SCRATCH ON THE PROBE TIP COULD OCCUR DUE TO ULTRASONIC VIBRATION, WHICH LEADS THE PROBE TIP TO BREAK AND FALL OFF INTO THE BODY CAVITY. IN ADDITION, THE HIGH-FREQUENCY (RF BIPOLAR) CURRENT FLOWS THROUGH THE METAL AND GENERATES SPARK DISCHARGE, WHICH MAY CAUSE BURNS AND DECREASE FUNCTIONALITIES.¿ OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.
AS REPORTED FOR THIS EVENT BY THE CUSTOMER, AFTER TWO MINUTES OF USING THE DEVICE IN AN UNKNOWN PROCEDURE, THE DEVICE PROBE BROKE OFF WHEN LIFTING THE OMENTUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1401370 | THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S | ULTRASONIC SURGICAL DEVICE | GEI | AOMORI OLYMPUS CO., LTD. | TB-0535FCS | PW307904 | 04953170383540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |