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

Model Number KD-620QR

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).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

The following events were reported in the endoscopica digestiva vol.30 no.4 2018.Article title: techniques for safely performing duodenal esd.Summary: kd-650q and/or kd-620qr were used in the study of treatment outcome comparing the pocket-creation method (pcm group) and conventional endoscopic submucosal dissection (conventional method: cm group).The total cases were 45 which were performed from 2006 to 2015.In the study, accidental symptoms occurred as follows.The number of accidental symptoms were calculated by multiplying the total cases by the incidence rate.- pcm group: perforation 7% (2 cases), postoperative bleeding 4% (1 case), - cm group: perforation 29% (5 cases), postoperative perforation 6% (1 case), emergency operation 6% (1 case), postoperative bleeding 18% (3 cases), the malfunction of the subject device has not been reported.This report is regarding kd-620qr, cm group, postoperative bleeding 3 of 3 cases.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, omsc could not evaluate the reported device.The exact cause of this issue could not be conclusively determined.However, omsc has only shipped devices which passed the inspection.From the reported information, it is assumed that the event did not occur due to malfunction of the device, but occurred as a general accidental symptom of the procedure.

• 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
• MDR Report Key: 7521631
• MDR Text Key: 108503911
• Report Number: 8010047-2018-00876
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-620QR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other