MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

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

Patient Problems Cyst(s) (1800); Fever (1858); Fistula (1862); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Ascites (2596); Liver Failure (4492)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.On october 6, 2021, medical safety officers, who have the medical licenses in olympus, reviewed as bellow.¿sonosurg and thunderbeat were used during the liver resection, and 29 cases of cdiii-iv were reported, including 4 deaths, 3 icu management, and 5 reoperations.Based on the patient's condition, the surgical complications/contingencies might occur.It is difficult to make judgments and to deny 100% relevance to the device because detailed confirmation is not possible based on the information in the literature alone.Olympus should confirm the author, it may elicit answers and senses from the authors.¿.

Event Description

Olympus medical systems corp.(omsc) received the literature "the clinical and biological impacts of the implementation of fast-track perioperative programs in complex liver resections: a propensity score-based analysis between the open and laparoscopic approaches¿.The purpose of the literature was to evaluate the impact of the fast-track approach in patients undergoing complex liver procedures and to analyze factors that influence morbidity and functional re- covery.Between january 2004 and september 2016, liver resections were performed at the hepatobiliary surgery division of san raffaele hospital, milan, italy.The minimally invasive liver surgery (mils) group (n = 102, study group) and the open group (n = 102, control group) were obtained.The procedures were performed using sonosurg ultrasonic dissector (olympus) and thunderbeat (olympus).In the literature, it was reported events as below, but there was no more information in the literature.Mils group (number of cases), conversion to laparotomy (20) , icu (1), postoperative mortality (2) , postoperative morbidity: clavien-dindo (cd) i¿ii (21), iii¿v (11), postoperative liver failure (2) , ascites (6), hemorrhage (2), biliary fistula (5), pleural effusion (11), abdominal collection (5), fever (12), need for reoperation (2), rate of readmission (4), rate of readmission within 7 days from discharge (1), open group: icu (2), postoperative mortality (2), postoperative morbidity: cd i¿ii (21), iii¿v (18), postoperative liver failure (6) , ascites (18), hemorrhage (3), biliary fistula (7), pleural effusion (21), abdominal collection (6), fever (18), need for reoperation (3), rate of readmission (5), rate of readmission within 7 days from discharge (1).On april 30, 2020, the first decision was as not reportable, because there is no malfunction and no outcome for the patient in the literature.In addition, the purpose of the literature was to compare how to the procedure and the others not to report mainly the complications by the procedures.On october 6, 2021, medical safety officers, who have the medical licenses in olympus, reviewed as bellow.¿sonosurg and thunderbeat were used during the liver resection, and 29 cases of cdiii-iv were reported, including 4 deaths, 3 icu management, and 5 reoperations.Based on the patient's condition, the surgical complications/contingencies might occur.It is difficult to make judgments and to deny 100% relevance to the device because detailed confirmation is not possible based on the information in the literature alone.Olympus should confirm the author, it may elicit answers and senses from the authors.¿ omsc tried to get new information from the author but could not get it.Based on the available information, a direct relationship between the olympus product and these complications could not be determined.However, 29 cases of cdiii-iv were reported, including 4 deaths, 3 icu management, and 5 reoperations might be serious injury, and the olympus devices might be associated with these complications.This is the report regarding 29 cases of cdiii-iv were reported, including 4 deaths, 3 icu management, and 5 reoperations for thunderbeat.

• Brand Name: OLYMPUS
• 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: 12750280
• MDR Text Key: 280056792
• Report Number: 8010047-2021-14060
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K172610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TB-0535FCS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other; Required Intervention