MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FC

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

Patient Problems Pleural Effusion (2010); Pneumonia (2011); Ascites (2596); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Death  

Manufacturer Narrative

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.

Event Description

It is reported in the literature titled: ¿usefulness of hepatectomy for hepatocellular carcinoma in the elderly (75 years old and over),¿ patient experienced adverse events and mortality during or after hepatectomy procedures using a thunderbeat.Case with patient identifier (b)(6) reports adverse events.Case with patient identifier (b)(6) reports mortality.Background/aim: there are various treatments for hepatocellular carcinoma such as hepatectomy, thermocoagulation therapy, hepatic artery therapy, drug therapy, and radiation therapy such as proton beam, but hepatectomy is the most reliable.It is recommended as a treatment method.One of the factors is that hepatectomy has become relatively safe with the determination of appropriate surgical indications and advances in perioperative management.On the other hand, the proportion of elderly people aged 75 and over in the total population of (b)(6) has consistently increased, and by 2020, it will account for 14.9% of the total population.Elderly people have various underlying diseases, and many patients have comorbidities in important organs such as the circulatory organs, respiratory organs, and urinary organs 4), and even poor preoperative nutritional status is observed.Therefore, a minimally invasive treatment method is selected for the treatment of the elderly.In many cases, strict risk evaluation and perioperative management are required.Correctly assessing the surgical risk of the elderly and performing perioperative management is a serious complication, long-term hospitalization, and postoperative management.It is extremely important to prevent the deterioration of performance status.Based on the current situation, this time, this study examined the preoperative condition, perioperative results and postoperative course of hepatectomy for hepatocellular carcinoma in the elderly aged 75 years and over and reported on the problems including some bibliographical considerations.Do.Methods: the subjects were 344 cases of hepatocellular carcinoma who underwent initial hepatectomy from january 2009 to august 2019 in our department.These cases were classified into two groups.Of 132 patients aged 75 years or older (elderly group) and 212 patients <75 years old (non-elderly group) at the time of surgery.In each group, background factors such as liver reserve and tumor, surgical factors such as surgical procedure, and postoperative complications were compared and examined.We compared age and gender, preoperative comorbidity, and blood biochemical tests as patient background factors.Hbsag and hcv antibody tests were performed as hepatitis screening tests.Estimated gfr value (egfr) was calculated and compared from age and serum creatinine level by the following simple formula.5).Male: egfr (ml / min / 1.73) = 194 × serum cr value (mg / dl)- 1.094 x age (years) -0'287, female: egfr (ml / min / 1.73) = (194 x serum cr value (mg / dl)-1.094 x age (years) '0.2 87) x 0.739.As tumor factors, liver tumor diameter, number of liver tumors, comorbid liver disease.Result: patient background / postoperative course compared with 236 patients who underwent hepatectomy from 1999 to 2008, the patient age (median) in the cases after 2009 was 67 years (median) until 2008.33-83 years old), cases after 2009: 72 years old (21-93 years old) and a prominent age difference was observed (p <0.001).Among the background factors of 344 cases since 2009, 31 cases (23.5%) in the elderly group had malignant tumors of other organs (including metachronous and synchronous), and 26 cases in the non-elderly group (including metachronous and simultaneous).12.3%) (p = 0.007, table 1).Preoperative comorbidities (heart disease, respiratory disease, renal disease, diabetes) were found in 80 cases (60.6%) in the elderly group and 110 in the non-elderly group.Regarding the blood test results for preoperative liver function, the total bilirubin level, prothrombin time, platelet count, etc.Were within the standard range in both groups, but the serum albumin level was in the elderly.The egfr value was 57.7 ± 16.5 for the elderly as for the result of preoperative renal function, which was 3.9 ± 0.5 g / dl, which was significantly lower than 4.0 ± 0.5 g / dl for the non-elderly (p = 0.030).It was (ml / min / 1.73), which was significantly lower than 79.0 ± 29.8 (ml / min / 1.73) in the non-elderly (p <0.001).In terms of surgical factors, there were no significant differences in the surgical procedure, operation time, bleeding volume, and the presence or absence of blood transfusion between the elderly group and the non-elderly group.Postoperative complications were not significantly different between the two groups in the incidence of superficial, deep incision and organ / cavity surgical site infections.There was not also a significant difference in the occurrence of respiratory-related complications, including postoperative pneumonia.In addition, the incidence of complications of grade 3a or higher in the clavien-dindo classification, including bile leakage, ascites retention, and liver failure was 23 (17.4%) in the elderly group and 53(25.0%) in the non-elderly group.There was no significant difference between the two groups.Postoperative complications occurred in 45 (23.7%) of 190 patients with preoperative complications, but there was no relationship between the two groups.The postoperative hospital stay was 13 days (3-97 days) in the elderly group and 12 days (4-124 days) in the non-elderly group, showing no significant difference.Conclusion this study suggested that surgical resection for hcc in the elderly can be performed safely after sufficient assessment.There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information was added to the following fields: d4, h6, h10.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 5 MM, 35 CM, FRONT-ACTUATED GRIP
• 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: 14652559
• MDR Text Key: 293686180
• Report Number: 8010047-2022-09797
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170337574
• UDI-Public: 04953170337574
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111202
• 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
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TB-0535FC
• 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: 06/15/2022
• 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): Death; Other