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

Model Number	TB-0009OF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Post Operative Wound Infection (2446)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported in the literature titled "the use of harmonic focus and thunderbeat open fine jaw in thyroid surgery: experience of a high-volume center," patients experienced adverse events after procedures using thunderbeat open fine jaw.Background: in thyroid surgery, achieving accurate hemostasis is fundamental in order to avoid the occurrence of complications.Energy-based devices are currently extensively utilized in this field of surgery.This study aims to compare harmonic focus and thunderbeat open fine jaw with regard to surgical outcomes and complications.Methods: patients submitted to total thyroidectomy in our center, between january 2017 and june 2020, were retrospectively analyzed.Based on the energy-based device utilized, two groups were identified: group a (harmonic focus) and group b (thunderbeat open fine jaw).Results: a total of 527 patients were included: 409 in group a and 118 in group b.About surgical outcomes, the mean operative time was significantly shorter in group b than in group a (p < 0.001), while as regards complications, the occurrence of transient recurrent laryngeal nerve injury was significantly greater in group b than in group a (p = 0.019).Conclusions: both harmonic focus and thunderbeat open fine jaw have proven to be effective devices.Operative times were significantly shorter in thyroidectomies performed with thunderbeat open fine jaw; however, the occurrence of transient recurrent laryngeal nerve injury was significantly greater in patients operated on with this device.Of the 527 patients enrolled, 409 were included in group a and 118 in group b.In group a, the average operative time was 87.35 ± 20.98 min, the average drain output on postoperative day 1 was 62.12 ± 23.38 ml, and the average postoperative stay was 2.93 ± 1.41 days.As regards complications, there were 83 (20.29%) cases of transient hypoparathyroidism, 18 (4.40%) cases of permanent hypoparathyroidism, 5 (1.22%) cervical hematomas, 7 (1.71%) unilateral rln lesions, 1 (0.24%) bilateral rln lesion, 5 (1.22%) transient rln lesions, 4 (0.98%) permanent rln lesions, and 3 (0.73%) wound infections.In group b, the average operative time was 74.47 ± 16.40 min, the average drain output on postoperative day 1 was 61.30 ± 23.19 ml, and the average postoperative stay was 3.02 ± 2.03 days.As regards complications, there were 22 (18.64%) cases of transient hypoparathyroidism, 7 (5.93%) cases of permanent hypoparathyroidism, 1 (0.85%) cervical hematoma, 5 (4.24%) unilateral rln lesions, 1 (0.85%) bilateral rln lesion, 6 (5.08%) transient rln lesions, 1 (0.85%) permanent rln lesion, and 1 (0.85%) wound infection.There is no report of device malfunction in any procedure described in this literature.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information was added to the following fields: h6, h10.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 OPEN FINE JAW
• Common Device Name: 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: 14888090
• Report Number: 8010047-2022-11212
• Device Sequence Number: 17688987
• Product Code: GEI
• UDI-Device Identifier: 04953170343346
• UDI-Public: 04953170343346
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TB-0009OF
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown