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

Model Number FD-410LR

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There were no scorched tissue and the foreign material at the distal end of the subject device.There was no abnormality of the resistance between the forceps and the plug of the handle.The subject device worked properly.There were no defects on the subject device.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the event occurred due to any of the following possible causes.The subject device was not connected to the cord or the cord was not connected to the power supply correctly.The current density decreased because the target area was immersed in blood or water.The above device handling has warned in the instruction manual as follows.Before use, prepare and inspect the instrument and a cord as instructed below.Should the slightest irregularity be suspected, do not use the instrument or a cord; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforation, bleeding, mucous membrane damage or thermal injury and may result in more severe equipment damage.Aspirate fluids such as mucus that adhere to the tube and body cavity tissue.Patient injury such as perforation, bleeding, mucous membrane damage and thermal injury of tissue could result if output is activated with these fluids adhering.

Event Description

During an endoscopic submucosal dissection (esd), the subject device was used.In the procedure, the doctor used the subject device for hemostasis, but the subject device did not activate output and could not stop bleeding.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the failure of stopping bleeding.

• 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: 9795646
• MDR Text Key: 221604150
• Report Number: 8010047-2020-01623
• Device Sequence Number: 1
• Product Code: KNS
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FD-410LR
• Device Lot Number: 9YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1