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 Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

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

Olympus reviewed a literature titled "thyroidectomy with energy-based devices: surgical outcomes and complications¿comparison between harmonic focus, ligasure small jaw and thunderbeat open fine jaw".Literature summary: the aim of this study was to compare harmonic focus (hf), ligasure small jaw (lsj) and thunderbeat open fine jaw (tb) in terms of surgical outcomes and complications.A total of 1,165 patients were included in this study: 1,012 in group a, 96 in group b and 57 in group c.Demographic data and histopathological findings were comparable between the three groups.About the postoperative stay and complications, no statistically significant difference was found.The mean operative time was 89.41±20.60 minutes in group a, 85.57±15.91 minutes in group b and 78.07±17.67 minutes in group c (p<0.01).However, the post-hoc test for all pairwise comparisons showed a statistically significant difference only between group a and group c.Hf, lsj and tb have proved to be safe and effective.The postoperative stay and complications were comparable between the three groups.Type of adverse events/number of patients, group c: unilateral recurrent nerve injury - (2).Since the literature described "thunderbeat", we selected "tb-0535fcs" which was shipped the most in the area and in the study period, was used, and etq is created.

Manufacturer Narrative

This is a supplemental report to correct the initial mdr.After receiving additional information from the author, the adverse events reported in the literature article have been determined not to be serious injuries.

Event Description

The author provided additional information: the olympus device did not cause or contribute to the adverse events experienced.

• 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: 14251408
• MDR Text Key: 290444464
• Report Number: 8010047-2022-07331
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: 05/09/2022
• 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
• Patient Outcome(s): Other