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 Problem Perforation (2001)

Event Date 12/30/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report the user's experiences and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.

Event Description

In the literature titled ¿endoscopic submucosal dissection for superficial barrett¿s neoplasia in korea: a single-center experience,¿ one patient perforation after an endoscopic submucosal dissection (esd) procedure using olympus devices.Case with patient identifier (b)(6) reports gif-260 used in the procedure.Case with patient identifier (b)(6) reports kd-650l used in the procedure.Case with patient identifier (b)(6) reports kd-610l used in the procedure.Case with patient identifier (b)(6) reports fd4-10lr used in the procedure.Study background/aim: while the incidence of barrett¿s neoplasia has been increasing in western countries, the disease remains rare in asian countries.Therefore, very few studies have investigated the endoscopic treatment for barrett¿s neoplasia in korea.Endoscopic submucosal dissection (esd) enables en bloc and complete resection of gastrointestinal neoplastic lesions.This study aimed to evaluate the therapeutic outcomes of esd for barrett¿s neoplasia in a single center in korea and to examine the predictive factors for incomplete resection.Methods: we conducted a retrospective observational study of 18 patients who underwent esd for superficial barrett¿s neoplasia (dysplasia and early cancer) between january 2010 and december 2019 at pusan national university hospital.The therapeutic outcomes of esd and procedure-related complications were analyzed.Results: en bloc resection, complete resection, and curative resection were performed in 94%, 72%, and 61% of patients, respectively.Histopathology (submucosal or deeper invasion of the tumor) was a significant predictive factor for incomplete resection (p=0.047).Procedure-related bleeding and stenosis were not observed, whereas perforation occurred in one case.During the median follow-up period of 12 months (range, 6¿74 months), local recurrence occurred in 2 patients with incomplete resection, one patient underwent repeat esd, and the other patient received concurrent chemoradiotherapy.The 3-year overall and disease-specific survival rates were 73% and 93%, respectively.Conclusion: esd seems to be an effective and safe treatment for superficial barrett¿s neoplasia in korea.Nevertheless, the suitability of esd for barrett¿s cancer cases should be determined considering the high risk of deep submucosal invasion no procedure-related bleeding or stenosis was observed.However, perforation occurred in 1 patient (6%) with severe alcoholic hepatitis and was treated successfully with antibiotics and restricted oral intake after clipping during the esd procedure.There is no report of olympus device malfunction described in this study.

• 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: 14347609
• MDR Text Key: 294672477
• Report Number: 8010047-2022-07992
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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: 04/10/2022
• 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