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

Model Number FD-410LR

Device Problems Break (1069); Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report has not yet been returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an unspecified procedure, the subject device was used.The device could not stop bleeding.No patient injury was reported.This is the report regarding the failure of stopping bleeding.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The foreign material stuck to the distal end of the subject device.The resistance between the forceps cups and the plug of the handle was high.After removing the foreign material, there was no abnormality of the resistance between the forceps cup and the plug of the handle.The subject device worked.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 contact condition between the patient and the patient plate was bad.The subject device was not connected to the cord or the cord was not connected to the power supply correctly.The current density decreased due to increasing of contact area between the tissue and the subject device.The target area was immersed in blood.The target area was immersed in water.The instruction manual of the device has described the method of connection of a code.The instruction manual of the device has already warned as follows.Pulling the tissue when applying the current.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• 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
• MDR Report Key: 8031859
• MDR Text Key: 125908789
• Report Number: 8010047-2018-02112
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K062517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FD-410LR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1