MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Model Number FD-411QR

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

Patient Problem Bradycardia (1751)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled ¿endoscopic hand suturing for mucosal defect closure after gastric endoscopic submucosal dissection may reduce the risk of postoperative bleeding in patients receiving antithrombotic therapy¿, patients experienced adverse events during or after procedures using olympus devices.Case with patient identifier (b)(6) will report the kd-650l used in the esd procedures.Case with patient identifier (b)(6) will report the fd-411qr used in the esd procedures.Case with patient identifier (b)(6) will report the fg-21l-1 used in the ehs procedures.Case with patient identifier (b)(6) will report the hx-610-090s used during the ehs procedures.Case with patient identifier (b)(6) will report the gif-2tq260m used during the ehs procedures.Case with patient identifier (b)(6) will report the through the scope needle holder used during the ehs procedures.Study aim: endoscopic hand suturing (ehs) is expected to decrease the risk of post-endoscopic submucosal dissection (esd) bleeding by closing mucosal defects.The study investigated the efficacy of ehs after gastric esd in patients with antithrombotic agents.Study method: prospective single-arm trial, patients taking antithrombotic agents for cardiovascular disease, arrhythmia, cerebrovascular disease and/or peripheral arterial disease and having <3cm gastric neoplasms were recruited.The mucosal defects after esd were closed by ehs in which the needle was delivered through an overtube, and the mucosal rim of the defect was continuously sutured in a linear fashion by manipulating the needle grasped with the needle holder, followed by cutting the remnant suture and retrieval of the needle.The primary endpoint was the incidence of postoperative bleeding within 4 weeks after esd.Results: twenty-two lesions in 20 patients (continuing anti platelet agents in 11, anticoagulant agents in eight, both in one) underwent esd followed by ehs.All defects (median size, 30 mm; range, 12¿51 mm) were completely closed by ehs and remained closed on postoperative day 3.The median number of stitches was six (range, 4-8) and median suturing time was 36 (range, 24¿60) min.There were no adverse events during/ after ehs or postoperative bleeding.Conclusions: postoperative bleeding was not observed in patients taking antithrombotic agents without perioperative cessation.Ehs appears to be useful for prevention of post gastric esd bleeding in high-risk patients.There was no report of olympus device malfunction in any procedure described in this literature.In the esd group, no patients experienced post-operative bleeding and one patient experienced severe bradycardia during the esd-procedure quickly completed without suturing.In the esh group, no patients experienced post operative bleeding.One patient experienced an acute myocardial infarction (ami) two days post procedure.Under control of cardiologists, heparin and a coronary vasodilator were administered intravenously immediately after onset.On post-operative day (pod) 6, the patients underwent pci and started receiving dual antiplatelet therapy with aspirin and clopidogrel sulfate.Follow-up endoscopy on pod 7 showed that the defect had closed completely without dehiscence.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.See update in g2.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.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Type of Device: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• 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: 13763296
• MDR Text Key: 291964782
• Report Number: 8010047-2022-04397
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170251535
• UDI-Public: 04953170251535
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062517
• 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: Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FD-411QR
• 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: 04/07/2022
• 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
• Patient Sex: Male