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 Fistula (1862)

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 identified the following literature article: "transoral ultrasonic surgery (touss) for oral cavity, oropharyngeal and supraglottic malignancy: a prospective study of feasibility, safety, margins, functional and survival outcomes" by pirabu sakthivel, alok thakar, and mario m.Ferna´ndez-ferna´ndez et al.This study reports on preliminary results with transoral ultrasonic surgery (touss) for oncologic resections of oral cavity, oropharyngeal and supraglottic malignancies.Eighteen patients with malignancies of oral cavity, oropharynx and supraglottis underwent touss with simultaneous neck dissection and adjuvant therapy as indicated, from january 2018 to april 2019.Margins were negative for ten patients (55.6%), close in five (27.8%), and positive in three patients (16.7%).Average touss set-up time was 22.5 min (range, 10¿30 min) and average touss primary tumor removal time was 35.3 min (range, 15¿60 min).Patients started tolerating oral feeds even in the second post op day (mean 6 days), and transitioning to complete oral feeds with removal of the nasogastric tube was achieved in all (mean, 16 days).The average hospital stay was 7.4 days (range 2¿16 days).Neck dissection when indicated was undertaken prior to primary tumor resection.The neck dissection was undertaken by the conventional open procedure.Neck closure was performed after completion of transoral resection to facilitate the pharyngeal closure from outside in cases of cervicopharyngeal communication using a sternomastoid muscle patch plug over the defect.In the latter part of this experience, prophylactic lingual artery ligation was undertaken with excision of oropharyngeal tumors.The patients were administered non-steroidal anti-inflammatory drugs and opioids for postoperative pain after extubation.Functional endoscopic evaluation of swallowing was performed to evaluate for swallowing function and ruling out aspiration before removing nasogastric tube.The physicians reported using a tb-0535fcs thunderbeat in all procedures and a endoeye flex 5 mm/2d videoscopes or endoeye flex 10 mm/3d videoscopes.However, the authors did not specify the adverse events in relation to the olympus devices used and therefore will be reported for all olympus devices.The following adverse events were reported for the olympus devices and includes 21 reports: (b)(6), ltf-190-10-3d: 2 unidentified patients had intraoperative lingual artery ligation performed.No intraoperative blood transfusions were necessary for any patient.(b)(6), ltf-190-10-3d: case 5: developed transient salivary contamination in the neck drain.The neck drain was non-functional; developed neck swelling and fistula; treated with pressure dressing.(b)(6), ltf-190-10-3d: case 7 developed minimal wound gaping and required neck resuturing.(b)(6), ltf-190-10-3d: case 8: developed transient salivary contamination in the neck drain with fistula treated with pressure dressing.(b)(6), ltf-190-10-3d: case 9: secondary hemorrhage required readmission with an emergency tracheostomy and ligation of lingual artery postop day 20.The patient was subsequently decannulated within 10 days.Patient died due to stroke at 15 months follow up.(b)(6), ltf-190-10-3d: case 10: secondary hemorrhage required readmission with an emergency tracheostomy and ligation of lingual artery postop day 2.The patient was subsequently decannulated within 10 days.Also developed transient salivary contamination and orocutaneous fistula treated with pressure dressing.(b)(6), ltf-190-10-3d: case 13: developed transient salivary contamination in the neck drain with orocutaneous fistula treated with pressure dressing.The patient also died due to regional recurrence of the malignancy at 13 months follow up.(b)(6), ltf-s190-5: 2 unidentified patients had intraoperative lingual artery ligation performed.No intraoperative blood transfusions were necessary for any patient.(b)(6), ltf-s190-5: case 5: developed transient salivary contamination in the neck drain.The neck drain was non-functional; developed neck swelling and fistula; treated with pressure dressing.(b)(6), ltf-s190-5: case 7 developed minimal wound gaping and required neck resuturing.(b)(6), ltf-s190-5: case 8 developed transient salivary contamination in the neck drain with fistula treated with pressure dressing.(b)(6), ltf-s190-5: case 9: secondary hemorrhage required readmission with an emergency tracheostomy and ligation of lingual artery postop day 20.The patient was subsequently decannulated within 10 days.Patient died due to stroke at 15 months follow up.(b)(6), ltf-s190-5: case 10: secondary hemorrhage required readmission with an emergency tracheostomy and ligation of lingual artery postop day 2.The patient was subsequently decannulated within 10 days.Also developed transient salivary contamination and orocutaneous fistula treated with pressure dressing.(b)(6), ltf-s190-5: case 13: developed transient salivary contamination in the neck drain with orocutaneous fistula treated with pressure dressing.The patient also died due to regional recurrence of the malignancy at 13 months follow up.(b)(6), tb-0535fcs: 2 unidentified patients had intraoperative lingual artery ligation performed.No intraoperative blood transfusions were necessary for any patient.(b)(6), tb-0535fcs: case 5: developed transient salivary contamination in the neck drain.The neck drain was non-functional; developed neck swelling and fistula; treated with pressure dressing.(b)(6), tb-0535fcs: case 7 developed minimal wound gaping and required neck resuturing.(b)(6), tb-0535fcs: case 8: developed transient salivary contamination in the neck drain with fistula treated with pressure dressing.(b)(6), tb-0535fcs: case 9: secondary hemorrhage required readmission with an emergency tracheostomy and ligation of lingual artery postop day 20.The patient was subsequently decannulated within 10 days.Patient died due to stroke at 15 months follow up.(b)(6), tb-0535fcs: case 10: secondary hemorrhage required readmission with an emergency tracheostomy and ligation of lingual artery postop day 2.The patient was subsequently decannulated within 10 days.Also developed transient salivary contamination and orocutaneous fistula treated with pressure dressing.(b)(6), tb-0535fcs: case 13: developed transient salivary contamination in the neck drain with orocutaneous fistula treated with pressure dressing.The patient also died due to regional recurrence of the malignancy at 13 months follow up.This report is 7 of 21 for (b)(6), tb-0535fcs: case 13: developed transient salivary contamination in the neck drain with orocutaneous fistula treated with pressure dressing.The patient also died due to regional recurrence of the malignancy at 13 months follow up.The death is not related to an olympus device.

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.

• 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: 13483569
• MDR Text Key: 289664141
• Report Number: 8010047-2022-02583
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• 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: 04/06/2022
• 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
• Treatment: LTF-S190-5 OR LTF-190-10-3D
• Patient Outcome(s): Other; Required Intervention