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 Unspecified Infection (1930); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Unspecified Gastrointestinal Problem (4491); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

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.

Event Description

Olympus reviewed the following literature: "shorter operation time and improved surgical outcomes in laparoscopic donor right hepatectomy compared with open donor right hepatectomy" by eui soo han, md, phd, kwang-woong lee, md, phd, kyung-suk suh, md, phd.This retrospective study was aimed to investigate the clinical outcomes and learning curve of pure laparoscopic donor hepatectomy operations performed by a single surgeon.The study also compared the surgical outcomes before and after overcoming the learning curve and described changes that occurred before overcoming the learning curve.A series of 150 consecutive donors right hemihepatectomy was performed, among those donors who underwent open donor right hepatectomy under the upper midline incision (umi) was assigned to the umi group (n = 50).And, pure 3d laparoscopic donor right hepatectomy (pldrh) was performed in a total of 100 patients and among the 100 cases of pldrh, the cumulative sum (cusum) analysis was used to determine the learning curve.Before overcoming the learning curve, the donors were classified into the initial group (n = 43), and after overcoming the learning curve, the donors were assigned to the recent group (n = 57).The study revealed that the operative time was significantly shorter in the recent pldrh group than in the umi and initial pldrh groups (p <.001), and the length of hospital stay in the recent pldrh group was significantly reduced compared to that in the umi group (p <.001).In conclusion, the study said that as technology advances, the surgical outcomes of pure laparoscopic donor right hepatectomy are comparable and the operation time of pure laparoscopic donor right hepatectomy is superior to those of open donor hepatectomy.  the authors used  thunderbeat and endoeye flex 3d laparoscope and reported the following adverse events: postoperative complications of donors: [upper midline incision (umi); n=50]: ileus - (2); wound problem - (2); biliary leakage requiring endoscopic stenting - (1); [initial; n=43].Intra-abdominal fluid collection requiring antibiotics - (2); biliary stricture requiring operation - (1); intra-abdominal bleeding requiring operation - (1); [recent; n=57]; portal vein thrombosis requiring stenting - (1).Early complications of recipient: [upper midline incision (umi); n=50].Infections - (13); bleeding - (5); cardiopulmonary complication - (4); renal complication - (1); gastrointestinal complication - (9); neurologic complication - (8); biliary leakage - (4); primary nonfunction - (1); [initial; n=43]; infections - (8); cardiopulmonary complication - (5); gastrointestinal complication - (5); neurologic complication - (5); biliary leakage - (3); portal vein complication - (2); primary nonfunction - (1); [recent; n=57]; infections - (10); bleeding - (8); cardiopulmonary complication - (6); gastrointestinal complication - (9); neurologic complication - (4); biliary leakage - (8); hepatic artery complication - (1); hepatic vein complication - (2); primary nonfunction - (1).This article includes 2 reports: patient identifier (b)(6): thunderbeat; patient identifier (b)(6): endoeye.This report is 1 of 2 for patient identifier (b)(6): thunderbeat. .

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 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: 13688621
• MDR Text Key: 291614603
• Report Number: 8010047-2022-04038
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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: 03/22/2022
• 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: ENDOEYE FLEX 3D LAPAROSCOPE
• Patient Outcome(s): Other