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

Model Number KD-650L

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

Patient Problems Perforation (2001); Aspiration Pneumonitis (4455)

Event Date 11/14/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled ¿clinical usefulness of red dichromatic imaging in hemostatic treatment during endoscopic submucosal dissection: first report from a multicenter, open-label, randomized controlled trial¿, patients experienced adverse events during or after endoscopic submucosal dissection (esd) procedure using a single-use electrosurgical knife kd-650.Study aim: to verify the efficacy and safety of red dichromatic imaging (rdi) in hemostatic procedures during endoscopic submucosal dissection (esd).Study method: multicenter randomized controlled trial of 404 patients who underwent esd of the esophagus, stomach, colorectum.Patients who received hemostatic treatments by rdi during esd were defined as the rdi group (n¿=¿204), and those who received hemostatic treatments by white light imaging (wli) were defined as the wli group (n¿=¿200).The primary endpoint was a shortening of the hemostasis time.The secondary endpoints were a reduction of the psychological stress experienced by the endoscopist during the hemostatic treatment, a shortened treatment time, and a non-inferior perforation rate, in rdi versus wli.Results: the mean hemostasis time in rdi (n¿=¿860) was not significantly shorter than that in wli (n¿=¿1049) (62.3¿±¿108.1 vs.56.2¿±¿74.6¿s; p¿=¿0.921).The median hemostasis time was significantly longer in rdi than in wli (36.0 [18.0¿71.0] vs.28.0 [14.0¿66.0] s; p¿=¿0.001) in a sensitivity analysis.The psychological stress was significantly lower in rdi than in wli (1.71¿±¿0.935 vs.2.03¿±¿1.038; p¿<¿0.001).There was no significant difference in the esd treatment time between rdi (n¿=¿161) and wli (n¿=¿168) (58.0 [35.0¿86.0] vs.60.0 [38.0¿88.5] min; p¿=¿0.855).Conclusions: hemostatic treatment using rdi does not shorten the hemostasis time.Rdi, however, is safe to use for hemostatic procedures and reduces the psychological stress experienced by endoscopists when they perform hemostatic treatment during esd.Mild aspiration pneumonia was found in two cases in rdi and one case in wli.Perforations were found in two cases in rdi and two cases in wli.None of the four perforations were caused by the hemostatic treatment, and all were cured by conservative treatment.There was no report of olympus device malfunction in any procedure described in this literature.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• 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: 13713869
• MDR Text Key: 287283919
• Report Number: 8010047-2022-04184
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170265761
• UDI-Public: 04953170265761
• 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: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-650L
• 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: 07/28/2022
• 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