THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
Report
- Report Number
- 9614641-2023-00838
- Event Type
- Injury
- Date Received
- June 13, 2023
- Date of Event
- April 20, 2023
- Report Date
- September 20, 2023
- Manufacturer
- AOMORI OLYMPUS CO., LTD.
- Product Code
- GEI
- UDI-DI
- 04953170383540
- PMA / PMN Number
- K211838
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL REPORT IS BEING CREATED TO INCLUDE ADDITIONAL INFORMATION RECEIVED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B5 DESCRIBE EVENT OR PROBLEM; D4 LOT NUMBER; D8 WAS THE DEVICE SERVICED BY A THIRD PARTY; D9 DEVICE AVAILABILITY AND RETURN DATE; H3 DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN; H6 TYPE OF INVESTIGATION. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS AND IS PENDING EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE CUSTOMER¿S REPORTED COMPLAINT WAS CONFIRMED. THE DEVICE EVALUATION FINDINGS ARE AS FOLLOWS: THE PROBE WAS BROKEN. THE BREAKAGE OF THE PROBE STARTED AT THE AREA WHERE THE CRACKS DEVELOPED. THERE WAS A CONTACT MARK ON THE PROBE INDICATING THAT THE PROBE WAS IN CONTACT WITH THE NON-INSULATED AREA. THE REAR END OF THE TISSUE PAD WAS WORN OUT. THERE WAS A CONTACT MARK ON THE NON-INSULATED OF THE GRASPING SECTION INDICATING THAT THE NON-INSULATED AREA WAS IN CONTACT WITH THE PROBE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN LESS THAN 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT (BROKEN PROBE) COULD NOT BE DETERMINED. HOWEVER, THE BROKEN PROBE LIKELY OCCURRED DUE TO THE FOLLOWING MECHANISM: 1. THE OUTPUT WAS ACTIVATED IN SEAL & CUT MODE WHILE THE GRASPING SECTION WAS GRASPING THICK TISSUE. THEREFORE, THE PROBE AND THE TISSUE PAD CAME INTO CONTACT AT THE REAR END OF THE GRASPING SECTION, CAUSING THE TISSUE PAD TO WEAR OUT. 2. THE NON-INSULATED AREA OF THE GRASPING SECTION AND THE PROBE CAME INTO CONTACT DUE TO WEAR OF THE TISSUE PAD. 3. THE OUTPUT IN SEAL & CUT WAS ACTIVATED WHILE THE NON-INSULATED AREA OF THE GRASPING SECTION WAS IN CONTACT WITH THE PROBE. AS A RESULT, A CONTACT MARK DEVELOPED. 4. A FORCE TO ACTIVATE THE OUTPUT IN SEAL &CUT MODE OR A FORCE TO GRASP TISSUE WAS APPLIED TO THE PROBE. THEREFORE, CRACKS DEVELOPED AT A CONTACT MARK CAUSING AN ERROR. 5. A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿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 THE 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.¿ ¿DURING THE TREATMENT, DO NOT ACTIVATE OUTPUT WHILE APPLYING THE PROBE TIP TO THE TISSUE WITH A STRONG FORCE, GRASPING THICK TISSUE, OR TWISTING THE HANDLE. ALSO, DO NOT INSERT THE HANDLE WHILE THE HANDLE IS TWISTED WITH RESPECT TO THE TISSUE, DO NOT GRASP IT, AND DO NOT ACTIVATE THE OUTPUT. OTHERWISE, THE PROBE TIP AND/OR GRASPING SECTION MAY BE DAMAGED, WHICH MAY RESULT IN FALLING OF THE PROBE TIP AND/OR TISSUE PAD.¿ THIS SUPPLEMENTAL REPORT INCLUDES AN UPDATE TO H3. ALSO, NEW INFORMATION HAS BEEN ADDED TO H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THE VERSION OF THE SOFTWARE OF THE USG-400 WAS VERSION 2.00. THE SETTING OF THE INTELLIGENT TISSUE MONITORING (ITM) WAS ¿ON.¿ IN THE HOSPITAL, THE SETTING OF THE ITM IS USUALLY ¿ON¿ WHEN USED. THE USER UNDERSTANDS THE CHARACTERISTIC OF THE ITM CLEARLY. THE USER DID NOT CHANGE THE SETTING OF THE ITM DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS A LOBECTOMY / VIDEO ASSISTED THORASCOPIC SURGERY (VATS).
THE CUSTOMER REPORTED TO OLYMPUS THAT AT THE END OF THE PROCEDURE, AN ERROR MESSAGE ALERTED AND UPON REMOVAL OF THE THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S, THE PROBE TIP HAD BEEN CUT AND WAS MISSING FROM THE DEVICE. THE PIECE WAS SEARCHED FOR TWO MINUTES AND THEN REMOVED FROM THE PATIENT'S CHEST AND DID NOT DAMAGE ANY TISSUE. THE PROCEDURE WAS A DISSECTION OF A THICKENED PLEURA IN THE THORACIC SURGERY SUITE. THERE WERE NO CONSEQUENCES TO THE PATIENT OTHER THAN A SLIGHT INCREASE IN THE DURATION OF THE PROCEDURE. THERE WAS NO PROLONGED HOSPITALIZATION OR ANOTHER INTERVENTION NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 945449 | THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S | ULTRASONIC SURGICAL DEVICE | GEI | AOMORI OLYMPUS CO., LTD. | TB-0535FCS | KR271739 | 04953170383540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |