MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN NEEDLE KNIFE V

Model Number KD-V451M

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

Patient Problems Abdominal Pain (1685); Fever (1858); Hemorrhage/Bleeding (1888); Pneumonia (2011)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Olympus reviewed the following literature titled: "clinicopathological characteristics of patients with pain after endoscopic submucosal dissection for gastric epithelial neoplasm" by jung-wook kim et al.    literature summary: this retrospective study was aimed to explore, both the incidence of epigastric pain after gastric endoscopic submucosal dissection (esd) and clinicopathologic factors associated with the pain in a large number of patients.The study retrospectively analyzed a prospectively collected registry of clinical, endoscopic, and pathologic results of 1266 patients who underwent esd for gastric adenoma or cancer.The data was analyzed included age, sex, pathology, specimen and tumor size, procedure time, and tumor location.A visual analogue scale (vas) was used to assess pain immediately after, and 2, 12, and 24 h after esd while the primary outcome was the use of painkillers (vas score > 4).Of 1226 patients, 461 (36.4%) needed a painkiller at least once after esd, were considered as the pain group.The study concluded that the factors inflicting pain after esd were included female sex, procedure time, and lesion location.Also suggested that the endoscopists should use preemptive or aggressive pain management in high-risk patients after esd.  the following adverse events were reported by the authors who used 5 olympus devices during the procedures.Failed esd (n=6).Post-esd bleeding (n=10).Aspiration pneumonia (n=2).Fever of unknown cause (n=1).Abdominal pain (n=461) received painkillers one or more times after the procedure; high-dose ppi treatment during the first 24 h after esd in the present study may have resulted in a lower frequency of post-esd pain.The authors did not specify the devices used in relation to the adverse events and therefore, all devices will be reported: patient identifier (b)(6): kd-v451m, single use 3-lumen needle knife v.Patient identifier (b)(6): kd-611l, single use electrosurgical knife.Patient identifier (b)(6): fd-410lr , single use electrosurgical hemostatic forceps.Patient identifier (b)(6): gif-q260j or gif-2tq260m ,evis lucera.This report is 1 of 4 for patient identifier (b)(6): kd-v451m, single use 3-lumen needle knife v.

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.

Manufacturer Narrative

This supplemental report is being submitted to provided additional information from the author.

Event Description

Additional information received from the author: the device lot/serial numbers are not available.In the medical opinion of the author, the olympus device did not cause the adverse events reported.When asked about the treatment course for the adverse events experienced, the author responded: the issue was mild and did not need treatment, the patient was monitored.

• Brand Name: SINGLE USE 3-LUMEN NEEDLE KNIFE V
• Type of Device: SINGLE USE 3-LUMEN NEEDLE 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: 13929560
• MDR Text Key: 288038879
• Report Number: 8010047-2022-05114
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170244148
• UDI-Public: 04953170244148
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K955247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-V451M
• 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: 07/13/2022
• 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: FD-410LR, UNKNOWN LOT.; GIF-Q260J OR GIF-2TQ260M, UNKNOWN SERIAL.
• Patient Outcome(s): Other