MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650

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

Patient Problems Perforation (2001); Blood Loss (2597)

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 serial 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 is no description of the device's malfunction.

Event Description

On december 7, 2020, olympus medical systems corp.(omsc) received the literature titled "comparison of short-term efficacy between endoscopic submucosal tunnel dissection and endoscopic submucosal dissection in treatment of wide esophageal squamous cell carcinoma of early stage".This study was conducted endoscopic submucosal tunnel dissection (estd) with endoscopic submucosal dissection (esd) for 40 patients with early-stage esophageal squamous cancer between january 2014 to december 2016.In the literature, it was reported that bleeding, perforation, stenosis, additional surgery, fever, and mediastinal emphysema have occurred.The additional surgery patient was an esophagectomy due to pathologic incomplete resection.Therefore, it was no relationship between the event and the subject device.Based on the available information, detailed information of the subject device was not provided, and there is no description of the relationship between the events and the subject device.However, omsc assumes that the perforation and the bleeding might be related to the subject device since the subject device was used for submucosal resection.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) for the type of the device (electrosurgical knife).

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• 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: 11044013
• MDR Text Key: 227203065
• Report Number: 8010047-2020-10723
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2020

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
• Device Operator: No Information
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/21/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other