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

Model Number KD-611L

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

Patient Problem Corneal Perforation (1792)

Event Type  malfunction  

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 april 6 omsc received the literature " predictive factors for technically difficult endoscopic submucosal dissection in large colorectal tumors".The purpose of the literature was to examine predictive factors for technical difficulty in large-sized colorectal esd (cr-esd).The procedure was performed using an endoscope (olympus; pcf-q260ai or pcf-q260azi) during the detection of lesions, and an endoscope (olympus; gif-260j or pcf-q260ji) and endoknife (olympus) during the cr-esd.The subjects were 36 patients with large tumor sizes (>10 cm2) from october 2012 to january 2015 and who had been referred to pla army general hospital for esd.In the literature, it was reported 7 immediate perforations.4 of 7 immediate perforations in large size colorectal group occurred during cr-esd.It was reported, three were successfully closed during or after esd, two were closed using several endoclips, and one was closed using an endoscopic pursestring suture.For the last patient, when the perforation was observed, we used endoclips to close it and successfully resected by second esd procedure two weeks later.No surgical intervention was needed.3 of 7 immediate perforations in small size colorectal group occurred during cr-esd.However, it was not found what severity level these perforations were and how treatment the surgeon performed.Other complications (3 local recurrences and 1 delayed bleedings) were reported.The literature wrote about the local recurrences as below.Local recurrence occurred in three patients during this period; all these patients were successfully treated by a second esd.Based on the available information, a direct relationship between the olympus product and these complications might be determined.However, 3 immediate perforations in small size colorectal group might be serious injury, and the olympus knife might be used when each perforation occurred.This is the report regarding 3 immediate perforations in small size colorectal group.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 11670185
• MDR Text Key: 269760409
• Report Number: 8010047-2021-04976
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170225963
• UDI-Public: 04953170225963
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: KD-611L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2021
• 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): Other