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

Model Number FD-411UR

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

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 endoscopic submucosal dissection, the subject devices was used.In the procedure, the user grasped the tissue and activated the foot pedal but the subject device did not activate output.The user tried new cords and made sure the setting was correct on the machine.However, it was not reported how the intended procedure was completed.No patient injury was reported.The subject device was discarded by the user.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.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 current density decreased due to burnt tissue attached to the distal end.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 because the target area was immersed in fluids such as water or blood.The above device handling has been 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: 9584836
• MDR Text Key: 198882083
• Report Number: 8010047-2020-00888
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170251542
• UDI-Public: 04953170251542
• Combination Product (y/n): N
• PMA/PMN Number: K062517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FD-411UR
• Device Lot Number: 92K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1