MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT OPEN FINE JAW; ULTRASONIC SURGICAL DEVICE

Model Number TB-0009OF

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 03/19/2021

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 serial 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 is no description of the device's malfunction.

Event Description

On (b)(6) 2021, olympus medical systems corp.(omsc) received the literature titled "a comparison of the thunderbeat and standard electrocautery devices in head and neck surgery: a prospective randomized controlled trial".This study was conducted on the total laryngectomy (tl) and neck dissection (nd) for 72 patients.In the literature, it was reported as follows; the consecutive patients with primary or recurrent laryngeal or hypopharyngeal cancer, scheduled for tl between (b)(6) 2018 and (b)(6) 2019.The study was conducted a randomized controlled study to evaluate the safety and efficacy of the thunderbeat open fine jaw (tb) during total laryngectomy surgery and neck dissection in comparison with standard electrocautery devices.In the procedure, blood loss occurred.And post-operative complications were reported.The complications grading iv and v were reported in (b)(4) cases.The grading was defined according to the clavien¿dindo (cd) classification.Omsc assumes that the blood loss was not identified as a serious adverse event because there is no indication in the literature.Whereas, omsc assumes that (b)(4) cases of grading iv/v complications were identified as a serious adverse event due to caused or contributed to a death or serious injury.Based on the available information, specific information on the subject device was not provided.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) of the subject device for the adverse event of (b)(4) cases of grading iv/v complications.

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 a correction and additional information from the author.

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.There was no malfunction of the thunderbeat device.The author stated: "the complications were usually pharyngo-cutaneous fistulas or postoperative bleeding.In some cases revision surgery was required: secondary closure of the fistula with or without an additional flap reconstruction in case of fistula and re-exploration in case of bleeding.".

• Brand Name: THUNDERBEAT OPEN FINE JAW
• 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: 12038728
• MDR Text Key: 257457474
• Report Number: 8010047-2021-07816
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170343346
• UDI-Public: 04953170343346
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K172610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TB-0009OF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other