MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP; INSTRUMENT

Model Number SB-0520FC

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

Patient Problems Paralysis (1997); Seroma (2069)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

Since the literature described "sonic beat", "sb-0520fc" as a representative product.The product was unknown but a representative product was chosen for processing purposes.Once the investigation has been completed, a supplemental report will be submitted with the device evaluation results.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "endoscopic surgery for thyroid tumors introduction of endoscopic thyroid surgery at kuma hospital".Literature summary endoscopic thyroid surgery cases at our hospital [target] -patients who underwent endoscopic thyroid surgery from may to (b)(6) 2023.-the number of patients was 20.-all patients underwent vans video-assisted neck surgery method.-intraoperative nerve monitoring device was used in all cases.-energy devices ligasure, sonic beat, harmonic [result] surgical time -average 194 minutes -within 3 months after start: 286 minutes (1-6 cases) -less than 4 months: 155 minutes (7-20 cases) bleeding volume -average 29ml -within 3 months after start: 42 ml (1-6 cases) -less than 4 months: 15 ml (7-20 cases) complications -postoperative vocal cord paralysis: 3 cases one case of thermal injury due to steam heat from an energy device hoarseness recovered after 6 months -postoperative bleeding: 0 cases -conversion to external incision: 0 case -postoperative subcutaneous seroma: 1 case (relieved by puncture drainage) type of adverse events/number of patients postoperative vocal cord paralysis (n=3) postoperative subcutaneous seroma (n=1).

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 and/or 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.Therefore, the root cause cannot be determined.This supplemental report includes additional information received from the author.B5 updated accordingly.Olympus will continue to monitor field performance for this device.

Event Description

An olympus device did not cause or contribute to the adverse events described in the article.Also, it was confirmed that there was no malfunction of an olympus device.

• Brand Name: SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP
• Type of Device: INSTRUMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18962538
• MDR Text Key: 338428326
• Report Number: 9614641-2024-00754
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 04953170370601
• UDI-Public: 04953170370601
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SB-0520FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• 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