MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.; SINGLE USE ELECTROSURGICAL KNIFE

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

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.

Event Description

On june 10, olympus medical systems corp.(omsc) received the literature "co-treatment with endoscopic laryngopharyngeal surgery and endoscopic submucosal dissection".The purpose of the literature was to compare the efficacies of treatment with endoscopic laryngopharyngeal surgery (elps) alone and elps combined with endoscopic submucosal dissection (esd).The procedure was performed using one of two types of knife (olympus; dual knife or electrosurgical needle knife: kd-600), a curved rigid laryngoscope (non-olympus), and an endoscope (olympus; gif-h260z).Between august 2014 and january 2020, a total of 103 lesions in 73 patients who underwent elps for pharyngeal cancer were included in this study.In the literature, it was reported two severe laryngeal edemas required a tracheostomy as follows.¿these 2 patients had undergone resection that required a long procedure time and slow procedure speed by elps alone.(case 1: procedure time, 157 min; procedure speed, 4.8 mm2/min; case 2: procedure time, 90 min; procedure speed, 6.1 mm2/min).Laryngeal edema is mainly caused by excessive surgical invasion, and these findings suggest that endoscopic treatment should be performed with a short procedure time and a fast procedure speed to prevent respiratory stenosis owing to laryngeal edema.¿ also, it was reported that 11 laryngeal edemas required conservative treatment, 3 bleedings, 1 stenosis, subcutaneous emphysema and dysphagia occurred.The author wrote, ¿subcutaneous emphysema and dysphagia were managed conservatively.Bleeding occurred in 3 patients after elps combined with esd.Two of these patients were taking antithrombotic drugs and 1 patient was receiving dialysis, and these 3 patients underwent endoscopic hemostasis in the operating room and the bleeding was safely managed.Stenosis occurred in 1 patient after elps combined with esd.In this patient, the tumor was located near the entrance of the esophagus, and the stenosis improved by oral administration of prednisolone and repeated balloon dilatation.¿ based on the available information, a direct relationship between the olympus product and these complications could not be determined.However, severe laryngeal edemas might be associated with using dual knife.This is the report regarding two severe laryngeal edemas.

• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 12063767
• MDR Text Key: 266450997
• Report Number: 8010047-2021-07939
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention