MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number UNKNOWN

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

Patient Problems Abscess (1690); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Model number: exact model of thunderbeat not provided.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00390.

Event Description

It is reported in the literature titled ¿thunderbeat¿ integrated bipolar and ultrasonic forceps in the whipple procedure: a prospective randomized trial,¿ patients experienced adverse events during and after procedures using thunderbeat.Study background/aim: the goal of the study was to test the safety and efficacy of the thunderbeat¿ in pancreatic surgery.As such, we present the first prospective, randomized trial to evaluate the use of thunderbeat¿ during the whipple procedure.Methods: this single-institution, prospective, randomized clinical trial was performed from january 2015 to august 2017 inclusion criteria were patients scheduled to undergo an elective whipple procedure, at least 22 years of age, karnofsky performance status greater than or equal to 80%.Patients were randomized in a 1:1 ratio and assigned to the thunderbeat¿ group or standard electrosurgery instruments.In the thunderbeat¿ group, dissection and hemostasis of vessels was performed using the thunderbeat¿ device.In the control group, ligasure (covidien, usa), scissors, ligatures, clips, and sutures were used for dissection and hemostasis as necessary based on attending surgeon preference.In order to minimize measurement bias, patients were blinded to the assigned operating technique.Surgeon blinding was not possible due to the nature of the study.Exclusion criteria were patients who were pregnant or breastfeeding, and patients who, in the surgeon¿s opinion at the time of dissection, would have their wellbeing compromised (e.G., bleeding or other independent acute health problems).All patients were prospectively followed for 90 days postoperatively in our complications database.Patient demographic, perioperative, and pathologic data were also collected.All complications were identified and graded prospectively using the modified accordion grading system (mags) 14 at a weekly conference, by clinical staff using methods and definitions we have previously published.16 patients were diagnosed with postoperative pancreatic fistula if there was any measurable drain output of fluid on or after postoperative day 3, with amylase content greater than three times the serum amylase activity in accordance with the international study group of pancreatic fistula (isgpf) guidelines.15 data on gland texture and duct size were not uniformly available for all patients.Estimated blood loss (ebl) was obtained from the intraoperative anesthesia notes where it is recorded during each surgical procedure and reflects the consensus of anesthesia and the primary surgeon.Time points for data collection were at screening, day of surgery, hospital discharge, 30-day post-op visit, and at 90 days as part of standard care.Univariate analysis was performed to evaluate for any differences between the thunderbeat¿ and conventional groups.The student t-test, mann-whitney test, and chi-square tests were performed when indicated.Statistical analysis was performed using spss (spss inc., version 23, chicago, il), probability values were considered statistically significant at less than 0.05 results: results: forty-four patients were enrolled to the study.Twelve were enrolled but not randomized to an arm and did not start the study due to reasons such as ineligibility, physician discretion, and because thunderbeat¿ was not in the operating room.Therefore, 32 patients were available for analysis.Of these, 19 patients were in the thunderbeat¿ arm and 13 were in the standard electrosurgery arm.Median age was 64 years, 65% of patients were male.Preoperative characteristics are summarized in table 1.Patients were well matched between groups with no significant differences regarding to age, smoking status, body mass index (bmi) and rates of neoadjuvant therapy.Indications for whipple were malignancy in 75% of patients and similar between groups.Tumor characteristics were also similar between groups including tumor size, percentage of cases requiring vascular resection, lymphovascular invasion and positive margin percentage.Average tumor size was 2.8 cm (sd of 0.95 cm), vascular resections were performed in 31% of cases, and half of cases had documented lymphovascular invasion.Margins were microscopically positive in 28% of cases.With the exception of one patient in the thunderbeat¿ group, surgeries were performed to grossly negative margins with frozen sections taken intraoperatively at the discretion of the attending surgeon.There was one patient in the thunderbeat¿ group in whom intraoperative frozen section revealed positive pancreatic margin but additional pancreas was not resected based on preoperative discussions with the patient.There were no significant differences noted in perioperative complication rates.Postoperative morbidity was similar between groups for all complications observed, with delayed gastric emptying (dge) being the most commonly observed complication (15.6% of patients) in each group.There was one patient in the thunderbeat¿ group who suffered a superficial wound infection that was treated by bedside drainage.One patient in the thunderbeat¿ group had a postoperative pancreatic fistula requiring depot octreotide.One patient in the standard electrosurgery group had a postoperative intra-abdominal fluid collection that required image guided percutaneous drainage.No patients required reoperation.There is no report of olympus device malfunction described in this study.

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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 14270836
• MDR Text Key: 294653731
• Report Number: 8010047-2022-07438
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• 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: 05/31/2022
• 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): Required Intervention; Other