MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. 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 Pneumonia (2011); Post Operative Wound Infection (2446); Pancreatitis (4481)

Event Date 03/27/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "comparison of short-term surgical outcomes of two-dimensional versus three-dimensional laparoscopic systems in laparoscopic cholecystectomy." the purpose of this study was to evaluate the usefulness of the 3d endoscopic system (3d) in laparoscopic cholecystectomy (lc).87 patients with lc were included in the study, divided into 2d and 3d groups.The breakdown was as follows: 44 patients in the 2d group and 44 patients in the 3d group.The 3d group had significantly more patients with a history of upper abdominal surgery than the 2d group.Intraoperative blood loss was 1.6±2.3 ml in the 2d group and 8.1±363 ml in the 3d group (p=0.004), showing a significant increase in the 3d group, but no difference in operation time or postoperative hospital stay.However, there was no difference in operative time or postoperative hospital stay.There was no difference in the background of patients with acute cholecystitis (10 patients in the 2d group and 26 patients in the 3d group) between the two groups, but there was no difference in operative time or postoperative hospital days.There were no differences between the two groups in acute cholecystitis in the 2d group (10 patients) and the 3d group (26 patients), but there were 5 patients in the 3d group who had undergone previous upper abdominal surgery.There was no difference in surgical outcomes between the two groups.There were no differences in surgical outcomes between the two groups.The present study did not demonstrate the usefulness of the 3d endoscopy system for lc.In order to investigate the usefulness of the 3d endoscopy system for lc in the future, the patients should be randomly assigned to the 3d group and the 2d group, and a forward-looking comparative study should be continued.In order to investigate the usefulness of the 3d endoscopic system for lc in the future, it is necessary to continue the comparative study and accumulate more cases.Type of adverse events/number of patients: wound infection 3 patients.Pneumonia 4 patients.Pancreatitis 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) : t3905.(b)(6): tb-0535fc.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

Since the literature described "thunderbeat", olympus selected "tb-tb-0535fc" which was shipped the most in the area and in the study period as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The author confirmed there were no olympus device malfunction during any procedure described in this literature and the author doesn't think olympus device cause or contribute to any of the patient adverse events(include death) described in this literature.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received from the author.The device history record was unable to be reviewed for this device since the serial and/or 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 events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.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): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16950928
• MDR Text Key: 315441589
• Report Number: 9614641-2023-00688
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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: 06/02/2023
• 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