MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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 Hematoma (1884); Hemorrhage/Bleeding (1888); Urinary Tract Infection (2120); Unspecified Gastrointestinal Problem (4491)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This event has been reported by the importer on mdr# (b)(4).

Event Description

The following literature article was identified by olympus: a pilot randomized controlled trial comparing thunderbeat to the maryland ligasure energy device in laparoscopic left colon surgery by jeffrey w.Milsom1 · koianka trencheva1, kota momose1, miroslav p.Peev1, paul christos2, parul j.Shukla1, kelly garrett1.Source: doi: 10.1007/s00464-021-08765-8.Abstract: background: the thunderbeat is a multi-functional energy device which delivers both ultrasonic and bipolar energy, but there are no randomized trials which can provide more rigorous evaluation of the clinical performance of thunderbeat compared to other energy-based devices in colorectal surgery.The aim of this study was to compare the clinical performance of thunderbeat energy device to maryland ligasure in patients undergoing left laparoscopic colectomy.Methods: prospective randomized trial with two groups: group 1 thunderbeat and group 2 ligasure in a single university hospital.60 subjects, male and female, of age 18 years and above undergoing left colectomy for cancer or diverticulitis were included.The primary outcome was dissection time to specimen removal (dtsr) measured in minutes from the start of colon mobilization to specimen removal from the abdominal cavity.Versatility (composite of five variables) was measured by a score system from 1 to 5 (1 being worst and 5 the best), and adjusted/weighted by coefficient of importance with distribution of the importance as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue manipulation 0.1.Other variables were: dryness of surgical field, intraoperative and postoperative complications, and mortality.Follow-up time was 30 days.Results: 60 patients completed surgery, 31 in group 1 and 29 in group 2.There was no difference in the dtsr between the groups, 91 min vs.77 min (p = 0.214).Thunderbeat showed significantly higher score in dissecting and tissue manipulation in segment 3 (omental dissection), and in overall versatility score (p = 0.007) as well as versatility score in segment 2 (retroperitoneal dissection p = 0.040) and segment 3 (p = 0.040).No other differences were noted between the groups.Conclusions: both energy devices can be employed effectively and safely in dividing soft tissue and sealing mesenteric blood vessels during laparoscopic left colon surgery, with thunderbeat demonstrating some advantages over ligasure during omental dissection and tissue manipulation.Study design: patients undergoing laparoscopic left colectomy for their medical condition were randomized with equal chances into one of two groups: group 1 thunderbeat, and group 2 ligasure.Population: sixty patients, male and female, age (b)(6) and above and american society of anesthesiologists (asa) class between 1 and 3, undergoing elective left laparoscopic colectomy for neoplasm or diverticulitis.Study instruments: thunderbeat 5 mm to 35 cm (olympus, (b)(6)).The tb device has been cleared under 510 (k) by fda and currently used for regular care.The surgeons were able to coagulate blood vessels up to 7 mm, cut and dissect during surgery.The device consists of: thunderbeat device and generator (fig.2a).The device is provided sterile and intended for single use only.The generators settings were the same for all cases in this study.All participating surgeons were trained in using tb and maryland ligasure devices as they are used daily for regular surgical care, and surgeons used the devices on at least 10 patients prior to this study.Equipment results: seventy three patients were enrolled in the study from february 2016 to april 2019, and sixty of them were randomized into the two groups: n=31 in group 1: thunderbeat and n=29 in group 2: ligasure and included in the analyses.Preoperative diagnosis in thunderbeat group (n=31): neoplasm, diverticulitis; preoperative comorbidities: hypertension, coronary artery disease, diabetes, others/unspecified; 1 patient converted to open surgery.Adverse events in thunderbeat group: intraoperative complications: sealing unsuccessful = 2, bleeding at time of sealing = 3.Bleeding mesentery dissection = 4, estimated blood loss 87mls±97 mls, postoperative ileus =1, wound hematoma incision = 1, uti = 1, reoperation = 2, readmission = 1.

Manufacturer Narrative

Correction h10 of the initial report, the suspect device has not been returned to olympus for evaluation.Multiple attempts were made to obtain additional information from the reporter but were unsuccessful.If additional information becomes available a supplemental report will be submitted.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 number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The event is not due to design.Based on the results of the investigation, a root cause was unable to be determined.The referenced literature did not describe any defects related to the product and no further information was able to be obtained from the reporter.Therefore, it is likely that the cause of the event was not due to a defect of the subject device.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12977226
• MDR Text Key: 286250348
• Report Number: 8010047-2021-15900
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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: 01/25/2022
• 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