MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. 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 Type  Injury  

Event Description

Olympus reviewed the following literature titled "current status of esd for colorectal neoplastic lesions in our department kanazawa medical university, department of gastrointestinal endoscopy".In 2012, endoscopic submucosal dissection (esd) for colorectal early malignant tumors became covered by insurance, and 10 years have passed.Colorectal esd has a high risk of difficulty and complications due to anatomical factors such as the thinness of the intestinal wall, the narrowness of the sarcoma, and the presence of folds.There were 124 colorectal esd cases performed since april 2012, including 65 cancers, 38 highly atypical adenomas, 5 ssa/p, and 16 carcinoid cases.The en bloc resection rate was 81.5% (101/124), and the main reasons why en bloc resection was not possible were scarring in 7 cases, tumor protrusion into the appendiceal orifice or ileal valve in 5 cases, and difficulty continuing treatment due to peristalsis or body movements in 2 cases.Intraoperative perforation was observed in 3 cases, but was successfully closed endoscopically.Postoperative pathology revealed sm2 (the degree of invasion into the submucosa) or deeper in 11 patients, 9 of whom underwent additional surgery; only 1 patient had residual cancer, but no lymph node metastasis was found.Colorectal esd has a high degree of procedural difficulty and a high risk of accidental injury due to anatomical factors, but safety has improved due to improvements in devices and an increase in the number of experienced cases.[type of adverse events / number of patients] : intraoperative perforation 3 patients.There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

Since the literature described "dual knife", "kd-650l" was selected as a representative product with the largest number of shipments in the area and during the study period.In addition, the hook knife, it knife 2, and it knife nano mentioned in the article were devices used prior to 2010, and the article reported on cases performed after april 2012.Therefore, olympus is only reporting the dual knife introduced after 2010.The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This supplemental report is being submitted to provided additional information from the author and to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: b5 and h6.The device history record was unable to be reviewed for this device since no product malfunction was reported.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it was presumed that the reported event is an accident or a complication associated with a surgical procedure using the subject device.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.

Event Description

Additional information received from the author: in the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported but were caused by the surgeon's technique.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15197756
• MDR Text Key: 297581874
• Report Number: 9614641-2022-00127
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• 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: 08/18/2022
• 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
• Treatment: S-O CLIPS
• Patient Outcome(s): Other; Required Intervention