MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GENERATOR

Model Number USG-400

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

Patient Problems Hemorrhage/Bleeding (1888); Nerve Damage (1979)

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 titled "outcome of transoral endoscopic thyroidectomy vestibular approach (toetva) in comparison with open thyroidectomy for benign thyroid nodules" by sadq ghaleb kadem, et al.Abstract open thyroidectomy; is the gold standard surgical procedure for thyroid diseases, but the incision scar in the anterior aspect of the neck due to this approach cannot be avoided and may results in a permanent cosmetic defect.Therefore, there is a need to improve postoperative quality of life, including cosmetics.Recently, transoral endoscopic thyroidectomy has been developed; it is a natural orifice thyroid surgery, minimally invasive and completely scar free.This study aimed to describe the outcome, patient¿s satisfaction, and complications after hemithyroidectomy for benign thyroid nodules by transoral endoscopic vestibular approach in comparison with open approach.This study was conducted in (b)(6), (b)(6) from august 2017 to june 2019 and was approved by a local ethical committee.Fifty patients with benign thyroid nodules who are candidate for hemithyroidectomy were included in the study; they were divided into two groups according to the method for thyroidectomy which was either conventional open or transoral endoscopic thyroidectomy vestibular approach based on the patients¿ preferences.All operations were performed by the same surgical team.The results of this study showed that 24 (48%) of them operated upon by transoral endoscopic thyroidectomy vestibular approach, while the remaining 26 (52%) patients have been operated upon by open thyroidectomy approach.Transoral endoscopic thyroidectomy vestibular approach reported significant longer operative time, has comparable rate of complications with an excellent cosmetic outcome and better postoperative patients¿ satisfaction in comparison to open thyroidectomy.In conclusion, transoral endoscopic thyroidectomy vestibular approach is a safe and feasible procedure with an excellent cosmetic outcome and better patients¿ satisfaction.At present, it is a relatively time-consuming procedure and, therefore, candidate patients with a strong motivation for scar free surgery are recommended.Adverse events: 2 cases of temporary recurrent laryngeal nerve palsy is considered a serious complication following this surgery; treated conservatively and resolved completely within 8 weeks.Temporary mental nerve palsy is a peripheral neuropathy; treated conservatively and resolved completely within few weeks cervical subcutaneous emphysema can cause life-threatening complications; treated conservatively and resolved completely within 24 hours, conversion to open thyroidectomy in 1 case due to uncontrolled intraoperative bleeding.This article includes 2 reports for the two olympus devices used: patient identifier (b)(6): usg-400.Patient identifier (b)(6): unknown sonicbeat.This report is 1 of 2 for patient identifier (b)(6): usg-400.

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 serial 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 based on the final investigation by omsc.Based on the results of the final investigation, there was no relationship between the device and the adverse event.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus medical systems corp.(omsc) confirmed that there was no mdr reportable malfunction or adverse event.Olympus could get new information from the author on august 24 as bellow.[new information form the author] regarding your questions about the postoperative cases of nerve palsy that reported in this study and its relatioship to olympus devices¿ i want to explain the following: 1- our study was not designated to evaluate the safety and efficacy of sonicbeat olympus device.2- there were many published studies proved the safety and efficacy of this device.In 2016, i published study in in title ( impact of the harmonic scalpel hemostasis in total thyroidectomy in comparison with conventional hemostatic technique) in the file attached below.This study proved the safety and efficacy of sonicbeat olympus device for hemostasis during thyroid surgery in comparison the conventional method.3- the nerve palsy reported in the study you mention was temporary and not related to the used of sonicbeat device and it may be related to tension and traction effect during thyroid mobilization.4- the cases of nerve palsy in this study was treated conservatively by follow up only and recovered completely with in two months.5- usg 400 work properely and no need to return the device.

• Brand Name: ULTRASONIC GENERATOR
• Type of Device: ULTRASONIC GENERATOR
• 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: 14015263
• MDR Text Key: 293929449
• Report Number: 8010047-2022-05697
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 04953170306747
• UDI-Public: 04953170306747
• Combination Product (y/n): N
• Reporter Country Code: IZ
• PMA/PMN Number: K172691
• 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,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: USG-400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN SONICBEAT
• Patient Outcome(s): Required Intervention; Other