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 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not 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.In the procedure, the user connected the generator and the subject device.When the user activated, the subject device could not coagulate.There was no patient injury reported.No further information was provided.This is the report regarding the failure of the coagulation.

Manufacturer Narrative

This is a supplemental report to provide additional information.The following information was additionally reported.The procedure was endoscopic submucosal dissection (esd) and the subject device was used for hemostasis.The procedure was completed with another device.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 and the plug of the handle was high.After removing the foreign material, there was no abnormality of the resistance between the forceps and the plug of the handle.The subject device worked properly.The manufacturing record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined.Omsc assumed that the reported event occurred due to any of the following possible causes.The current density decreased due to burnt tissue attached to the distal end.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.

• 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
• MDR Report Key: 9619912
• MDR Text Key: 220810694
• Report Number: 8010047-2020-00987
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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: 96K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1