MAUDE Adverse Event Report: AOMORI 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 Pneumonia (2011); Urinary Tract Infection (2120); Post Operative Wound Infection (2446); Liver Failure (4492); Unspecified Kidney or Urinary Problem (4503)

Event Date 07/10/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, safety of laparoscopic hepatectomy in patients with severe comorbidities-a propensity score matched analysis.Literature summary: [abstract] background: laparoscopic hepatectomy (lh) is nowadays considered as the standard of care for various liver malignancies.However, studies focusing on perioperative outcome after lh in patients with severe comorbidities are still sparse.Methods: 247 patients, who underwent lh between january 2016 and march 2020 at european surgical center aachen maastricht (escam) were retrospectively analyzed regarding surgical outcome.All patients were categorized according to the asa guidelines and a propensity score matched (psm) analysis was performed to compare patients with severe comorbidities with patients with minor or no comorbidities.Results: after psm, no statistically significant differences regarding clinical characteristics were observed.We performed major resections in 26.4% of h-asa(asa > 2) patients and 19.4% of 1-asa (asa<2) patients, respectively (p =.322).Overall morbidity (clavien-dindo>1) was observed more frequently in the h-asa group (h-asa: 25.0% vs.1-asa: 8.3%; p =.007) while analysis of major morbidity(clavien-dindo>3b) showed a non-significant tendency for more complications in h-asa patients (h-asa: 8.3% vs.1-asa: 1.4%; p =.053).A subgroup analysis identified major resection (hr = 5.05; p =.006) as an independent risk factor for the occurrence of any postoperative complication and chronic kidney disease (hr = 22.59;p =.030) and liver fibrosis (hr = 30.16; p =.031) as risk factors for the occurrence of major complications in h-asa patients.Conclusion: lh in patients with severe systemic comorbidities shows a strong tendency towards an increased rate of major complications.Careful patient selection with respect to the planned extent of resection and the presence of chronic kidney disease and liver fibrosis should be performed to improve perioperative results.Type of adverse events/number of patients: clavien-dindo v (death) - 4.Acute kidney injury - 2.Urinary tract infection - 3.Hypokalemia - 2.Surgical site infection - 6.Binary leakage - 5.Acute liver failure - 1.Wound infection - 3.Pneumonia - 6.This article includes 2 reports: (b)(4).(for injury).(b)(4).(for death).This complaint is (b)(4).

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information from the author and the results of 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.

Event Description

Additional information received from the author: in the medical opinion of the author, the olympus devices did not cause or contribute to the adverse events.The author stated the events happened mainly due to the condition of the patient's liver, and there was no malfunction of the olympus 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.; 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: 15288616
• MDR Text Key: 298566695
• Report Number: 9614641-2022-00197
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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: 08/29/2022
• 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
• Treatment: NON-OLYMPUS DEVICES:CAUTERY,; NON-OLYMPUS: ULTRASONIC SURGICAL ASPIRATOR; NON-OLYMPUS:VASCULAR STAPLERS OR POLYMER CLIPS
• Patient Outcome(s): Other; Required Intervention