MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-620

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

Patient Problem 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 lot number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. Based on the reported event, it is presumed that the reported complication was not due to the malfunction of the device.

Event Description

On april 27, 2020, olympus medical systems corp. (omsc) received literature titled ¿efficacy and suitable indication of colorectal endoscopic submucosal dissection using a balloon-assisted endoscope¿. In the literature, it was reported that intraoperative perforation occurred with two patients and post operative bleeding occurred with one patient. Two cases of perforation were conservatively managed by medical treatment after endoscopic closure using endoclips. The postoperative bleeding was managed conservatively using endoclips. The literature indicated that the electrosurgical knife (kd-650q or kd-620qr) might be used for the procedure. Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined. Therefore, omsc will submit 2 medical device reports (mdr) for each event. This report is 2 of 2 reports for the postoperative bleeding of the electrosurgical knife.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-620
• 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: 10082666
• MDR Text Key: 197998779
• Report Number: 8010047-2020-02867
• 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: health professional,literatur

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 04/27/2020
• 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

Patient Treatment Data

Date Received: 05/22/2020 Patient Sequence Number: 1