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 Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article can be accessed at: doi: 10.21037/jgo-21-391.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature: "prognosis of rectal neuroendocrine tumors after endoscopic resection: a single-center retrospective study" by yue zheng, kehang guo1, and ruijie zeng et al.The study was aimed to investigate the efficacy and outcomes of different types of endoscopic resection in patients with rectal neuroendocrine tumors (nets), by analyzing the tumor morphology along with the rates of complete resection, complications, and outcomes.A total of 98 patients with rectal nets were included to evaluate the en bloc resection rate and histopathological complete resection rate (h-cr) of the lesions.And also investigated for complications such as; postoperative perforation and delayed postoperative hemorrhage.The study reported the en bloc resection rate of the modified endoscopic mucosal resection (emr) and endoscopic submucosal dissection (esd) treatment groups was 97.2% (35/36) and 100% (62/62), respectively.No adverse events except one delayed postoperative hemorrhage and no tumor recurrence or tumor-related death occurred.Modified emr and esd were concluded as safe and effective endoscopic approaches for the resection of rectal nets =15 mm in diameter.However, the study warranted a comprehensive preoperative evaluation of risk factors including, the depth of tumor invasion and tumor diameter for endoscopic resection.The authors used multiple olympus devices and reported the following adverse event: delayed postoperative hemorrhage: one patient experienced a delayed postoperative hemorrhage, which was successfully controlled after endoscopic interventions.Delayed postoperative hemorrhage refers to a hemorrhage that cannot spontaneously stop within 24 h after endoscopic resection and requires additional clinical interventions.Patient identifier (b)(6): kd-650l.Patient identifier (b)(6):gif-q260j.Patient identifier (b)(6): gif-q260.Patient identifier (b)(6): kd-610l.This report is 4 of 4 for patient identifier (b)(6): kd-610l.

Manufacturer Narrative

This supplemental report is being submitted to provide the author's response and the results of the legal manufacturer¿s investigation.New information added to b5, h6, and h10.Device history records review was not performed since the serial number was not provided.Olympus ships product manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.

Event Description

Additional information was received from the author: only one patient had bleeding, and the operation was prolonged.At that time, hemostatic clips were used for treatment, and no harm was caused to the patient, and the patient has recovered.The author also reported his medical opinion and does not think the adverse event was caused by the olympus 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: 13686560
• MDR Text Key: 291355017
• Report Number: 8010047-2022-04030
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170265761
• UDI-Public: 04953170265761
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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: 03/11/2022
• 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: GIF-Q260J, GIF-Q260, KD-610L.
• Patient Outcome(s): Other