MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number KD-655Q

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: colonoscope with waterjet instrument-either cf-h290, cf-hq290 or pcf-h290t, attachment d-201-12704, 3.0 suture, coagrasper fd-411qr, and fs-5q-1.This report is being submitted report adverse events and to provide investigation results no physical evaluation/inspection could be conducted on the suspect device as it was not returned to olympus.The device history record (dhr) for the complaint device could not be reviewed since the serial number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.There was no report of olympus device malfunction and no information connecting the cause of the reported events to the device.For these reasons, the definitive cause of the reported events could not be determined.

Event Description

It is reported in the literature titled ¿effectiveness of counter traction using a clip with a looped thread for colorectal endoscopic submucosal dissection,¿ patients experienced adverse events during or after endoscopic submucosal dissection procedures using olympus devices.Case with patient identifier (b)(6) reports: tac-esd group (n-19)-device: hx-610-135.Case with patient identifier (b)(6) reports: tac-esd group (n-19)-device: kd-6555q.Case with patient identifier (b)(6) reports: conventional esd (cesd)- group (n-42) device: kd-6555q.Case with patient identifier (b)(6) reports: looped thread (lt) group (n-46)device: kd-6555q.Study aim: the present study was designed to evaluate the safety and effectiveness of a novel traction method.Method: in (b)(6) 2018, we introduced a counter traction method using a clip with a lt.We treated 120 consecutive colorectal lesions in 119 patients using esd before and after the introduction of this traction method at the yodogawa christian hospital between january 2017 and april 2019.Esd was indicated for lesions sized > 20 mm or for those sized < 20 mm that were expected to have fibrosis and were deemed difficult to resect en bloc with the snare.Esd was performed by four endoscopists who had performed at least 100 esds and 10 colorectal esds.According to the japanese classification [11], laterally spreading tumors (lsts) were classified into laterally spreading tumors granular type (lst-g) and laterally spreading tumors non-granular type (lst-ng).Polypoid lesions, such as type 0-i of the paris endoscopic classification [12], were also defined as elevated type.A total of two lesions in two patients were excluded because of interrupting esd.In one patient, esd was interrupted due to acute exacerbation of chronic heart failure, and in the other patient, esd was interrupted because of severe muscle retraction with submucosal invasion.Results: total 68 lesions in 67 patients were treated before the intro duction of the method and esd was performed using various methods.Forty-two lesions were resected using conventional esd; of these, seven located in the rectum or the sigmoid colon were resected using normal clip with line method, the same method used for esd performed in esophageal cancer [13] (to set the clip and thread, the endoscope was withdrawn and reinserted), and 19 were resected using traction-assisted colorectal esd (tac-esd) [14].The 42 lesions resected using conventional esd were allocated to the conventional esd group (cesd group), and 19 lesions resected using tac-esd were allocated to the tac group.Seven lesions except for these two groups were excluded from this study.The other 50 lesions in 50 patients who were treated after the introduction of the method were allocated to the lt group.In the lt group, esd was pe formed for 46 lesions using the lt counter traction method.The four lesions were resected without lt traction because the good visibility of the submucosal layer could be maintained owing to gravity.Therefore, these four lesions were excluded.Finally, 107 lesions in 107 patients were analyzed in the study.Conclusion: this counter traction method has the potential to be one of the most useful traction methods for colorectal esd because it addresses the limitations of previously reported methods.Further prospective multicenter studies are required to elucidate the efficacy of this method more precisely in the tac-esd group, one patient experienced bleeding and one patient experienced perforation.In the cesd group, three patients experienced bleeding and 2 patients experienced perforation.In the lt group, three patients experienced bleeding and one patient experienced perforation.All patients in whom perforations and bleeding were observed were successfully treated with endoscopy.The perforation sites were closed with a clip during the procedures.Hemostasis was performed with clip or forceps; thus, emergency operation could be avoided.There is no report of olympus device malfunction described in this study.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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: 14089786
• MDR Text Key: 294607059
• Report Number: 8010047-2022-06147
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170405631
• UDI-Public: 04953170405631
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-655Q
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention