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

Model Number KD-650Q

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

Patient Problems Blood Loss (2597); No Code Available (3191)

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 (b)(6) 2021, olympus medical systems corp. (omsc) received the literature titled "long-term outcomes of colorectal endoscopic submucosal dissection in elderly patients". This study was conducted the colorectal endoscopic submucosal dissection (esd) for 482 patients between (b)(6) 2005 to (b)(6) 2013. In the literature, it was reported that 30 patients of intraoperative perforations including a patient who required emergency surgery, one delayed perforation, one intraoperative bleeding who required emergency surgery, 8 patients of postoperative bleedings. And 18 patients were dead during the follow-up period. Based on the available information, the delayed perforation and the postoperative bleeding were not reported in a direct relationship with the olympus products. And, reported deaths were the cause of patient diseases. Therefore, it was no relationship between the event and the subject device. However, omsc assumes that the intraoperative perforation and the intraoperative bleeding might be related to the subject device since the subject device was used for esd. Based on the available information, detailed information on the subject device was not provided. There is no description of the device's malfunction. Omsc will submit two medical device reports (mdr) of the electrosurgical knife for the intraoperative perforation and the intraoperative bleeding. This is a report regarding intraoperative bleeding.

• 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: 11184215
• MDR Text Key: 233590713
• Report Number: 8010047-2021-01546
• 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

• Type of Report: Initial
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: KD-650Q
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/05/2021
• 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

Patient Treatment Data

Date Received: 01/18/2021 Patient Sequence Number: 1