MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-620

Model Number KD-620QR

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

Patient Problems Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987)

Event Date 06/24/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Olympus reviewed the following literature titled "our endoscopic outcomes and treatment considerations for non-papillary duodenal epithelial tumors." literature summary the advent of cold snare polypectomy (csp), which carries very little risk of perforation, and underwater emr (uemr), which facilitates grasping of the lesion, have greatly advanced endoscopic treatment of non-papillary duodenal epithelial tumors.However, it still requires a high level of expertise and requires proficiency in diagnosing indications and handling contingencies.At our hospital, duodenal esd has been the mainstay of treatment using the hook knife.We will review the results of duodenal esd performed at our hospital and introduce various suture methods (clip snare, clip with thread, rolm, and cccm) to prevent accidental injury.Type of adverse events/number of patients perforation (7) delayed bleeding (3) delayed perforation (3) perforation requiring endoscopies and suturing (2) this literature article requires 2 reports.The related patient identifiers are as follows: -(b)(4) gif-q260j gastrointestinal videoscope -(b)(4) kd-620qr electrosurgical knife this medical device report is for patient identifier (b)(4).There is no report of any olympus device malfunction in any procedure described in this study.

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 serial and/or 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.Therefore, the root cause cannot be determined.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the information supplied by the author of the study.Please refer to the following section for the new information from the author: b5.

Event Description

The author of the study provided additional information indicating no olympus device malfunctioned during any procedure reported in the study, and no olympus device caused or contributed to any adverse events reported.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9614641.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-620
• 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 (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17409638
• MDR Text Key: 320016937
• Report Number: 9610595-2023-10720
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170251504
• UDI-Public: 04953170251504
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-620QR
• 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
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 08/03/2023; 09/20/2023; 05/06/2024
• Supplement Dates FDA Received: 08/31/2023; 09/22/2023; 05/06/2024
• 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: GIF-Q260J GASTROINTESTINAL VIDEOSCOPE
• Patient Outcome(s): Required Intervention