MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD.OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Pleural Effusion (2010); Post Operative Wound Infection (2446); Bowel Perforation (2668); Unspecified Hepatic or Biliary Problem (4493)

Event Date 05/31/2022

Event Type  Injury  

Event Description

It is reported in the literature titled ¿robotic vs.Laparoscopic liver surgery: a single center analysis of 600 consecutive patients in 6 years,¿ patient experienced adverse events during and after procedures using thunderbeat.Background while laparoscopic liver surgery has become a standard procedure, experience with robotic liver surgery is still limited.The aim of this prospective study was to evaluate safety and feasibility of robotic liver surgery and compare outcomes with conventional laparoscopy.Methods we here report the results of a single-center, prospective, post-marketing observational study investigating the safety and feasibility of robotic liver surgery.Baseline characteristics, surgical complexity (using the iwate score), and postoperative outcomes were then compared to laparoscopic liver resections performed at our center between january 2015 and december 2020.A propensity score-based matching (psm) was applied to control for selection bias.Results one hundred twenty-nine robotic liver resections were performed using the da vinci xi surgical system (intuitive) in this prospective study and were compared to 471 consecutive laparoscopic liver resections.After psm, both groups comprised 129 cases with similar baseline characteristics and surgical complexity.There were no significant differences in intraoperative variables, such as need for red blood cell transfusion, duration of surgery, or conversion to open surgery.Postoperative complications were comparable after robotic and laparoscopic surgery (clavien¿dindo=3a: 23% vs.19%, p=0.625); however, there were more bile leakages grade b¿c in the robotic group (17% vs.7%, p=0.006).Length of stay and oncological short-term outcomes were comparable.Conclusions we propose robotic liver resection as a safe and feasible alternative to established laparoscopic techniques.The object of future studies must be to define interventions where robotic techniques are superior to conventional laparoscopy.After robotic liver resections, patients spent a median of one night at the icu and were discharged from hospital after a median of 8 days.Ninety-day postoperative over all morbidity was 38%, with severe complications (clavien¿dindo=3) occurring in 23% of all cases.The most frequent type of complication was bile leakage, which was detected in 22 cases.Two of these cases required surgery, classifying as grade c bile leakage, while the remaining 20 cases were grade b.One patient (1%) died after robotic liver resection.This cirrhotic patient, who also had a pre-existing pulmonary disease, suffered a bile leakage grade c after right hepatectomy and subsequently developed pneumonia and multiorgan failure.There is no report of device malfunction in any procedure described in this study.Case with patient identifier (b)(6) reports the adverse events experienced by patients case with patient identifier (b)(6) reports the one patient that died during the study period.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being updated to report additional information provided by the authoring physician.

Event Description

Update: additional information provided by the authoring physician: "thank you for your inquiry and interest in the publication.We have only used the thunderbeat in the initial phase of laparoscopy.We are not aware of any malfunctions in the sense of cirs (critical incident reporting systems, intraoperative malfunctions and failures).Also, no deaths have occurred, or complications have arisen due to the thunderbeat.".

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15550021
• MDR Text Key: 301253623
• Report Number: 9614641-2022-00421
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention