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 Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Unspecified Hepatic or Biliary Problem (4493)

Event Date 02/27/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: high definition white light and near infra-red fluorescence (nirf) scope: either visera elite ii, hopkins ii telescope (karl storz), or pinpoint (novadaq).The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.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 study titled "evaluation of accuracy of laparoscopic liver mono-segmentectomy using the glissonian approach with indocyanine green fluorescence negative staining by comparing estimated and actual resection volumes a single center retrospective cohort study," patients experienced adverse events during or after laparoscopic liver mono-segmentectomy (llms) using a high definition white light and near infra-red fluorescence (nirf) scope: either visera elite ii, hopkins ii telescope (karl storz), or pinpoint (novadaq) and either a vessel sealing device (ligasure-coviden) or ultrasonic dissector (thunderbeat) study aim: to evaluate the accuracy and safety of llms using the glissonian approach with indocyanine green fluorescence (icg) negative staining.  study method: single-center retrospective cohort evaluation of 74 patients eligible for llms.Pre-operative three dimensional computerized tomography (ct) surgical simulation was used to determine estimated liver resection volume (elrv) which was then compared with actual liver resection volume (alrv) obtained from the actual liver resection mass.The llms accuracy was also evaluated based on surgeon's experience (attending physician [as] or trainee surgeon [ts]).  results: estimated liver resection volumes significantly correlated with the alrv in all cases.Moreover, the ts conducted llms also showed acceptable differences between elrv and alrv when compared with as conducted llms.There were no intergroup differences in estimated blood loss, operation time, time of pringle maneuver.Post-operative complications and length of post-operative hospitalization.Conclusions: laparoscopic liver mono-segmentectomy with the glissonian approach using icg negative imaging ensured safe and accurate procedure owing to facilitated visualization of the resection line.This approach was effective in avoiding post-operative liver dysfunction and securing radical resection.Adverse events reported in this study: estimated blood loss range141ml-741ml-three patients requiring blood transfusion.Bile leakage (5)-treatment not specified.Surgical site infection (5)-treatment not specified.Intra-abdominal infection (5)-treatment not specified.There is no report of olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

Concomitant products: high definition white light and near infra-red fluorescence (nirf) scope: either visera elite ii, hopkins ii telescope (karl storz), or pinpoint (novadaq).The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.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 study titled "evaluation of accuracy of laparoscopic liver mono-segmentectomy using the glissonian approach with indocyanine green fluorescence negative staining by comparing estimated and actual resection volumes a single center retrospective cohort study," patients experienced adverse events during or after laparoscopic liver mono-segmentectomy (llms) using a high definition white light and near infra-red fluorescence (nirf) scope: either visera elite ii, hopkins ii telescope (karl storz), or pinpoint (novadaq) and either a vessel sealing device (ligasure-coviden) or ultrasonic dissector (thunderbeat) study aim: to evaluate the accuracy and safety of llms using the glissonian approach with indocyanine green fluorescence (icg) negative staining.  study method: single-center retrospective cohort evaluation of 74 patients eligible for llms.Pre-operative three dimensional computerized tomography (ct) surgical simulation was used to determine estimated liver resection volume (elrv) which was then compared with actual liver resection volume (alrv) obtained from the actual liver resection mass.The llms accuracy was also evaluated based on surgeon's experience (attending physician [as] or trainee surgeon [ts]).  results: estimated liver resection volumes significantly correlated with the alrv in all cases.Moreover, the ts conducted llms also showed acceptable differences between elrv and alrv when compared with as conducted llms.There were no intergroup differences in estimated blood loss, operation time, time of pringle maneuver.Post-operative complications and length of post-operative hospitalization.Conclusions: laparoscopic liver mono-segmentectomy with the glissonian approach using icg negative imaging ensured safe and accurate procedure owing to facilitated visualization of the resection line.This approach was effective in avoiding post-operative liver dysfunction and securing radical resection.Adverse events reported in this study: estimated blood loss range141ml-741ml-three patients requiring blood transfusion.Bile leakage (5)-treatment not specified.Surgical site infection (5)-treatment not specified.Intra-abdominal infection (5)-treatment not specified.There is no report of 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.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.

Manufacturer Narrative

This report is being supplemented to provide additional information in the following fields: b3, h6, h10.

• 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: 13590227
• MDR Text Key: 286052124
• Report Number: 8010047-2022-03487
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K211838
• 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,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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: 07/25/2022
• 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