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

Model Number	FD-412LR
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During an endoscopic submucosal dissection, the subject device was used.During the procedure, the doctor used the subject device for hemostasis, but the subject device did not activate output.The intended procedure was completed with another device.There was no patient injury reported.
Additional 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 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 target area was immersed in blood or water.The current density decreased due to increasing of contact area between the water and the subject device.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.
Additional Manufacturer Narrative
This supplemental report is submitting to correct "device product code".

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Common Device Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7600282
• Report Number: 8010047-2018-01147
• Device Sequence Number: 1501301
• Product Code: KNS
• UDI-Device Identifier: 04953170359804
• UDI-Public: 04953170359804
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2019

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
• Operator of Device: No Information
• Device Model Number: FD-412LR
• Device Lot Number: 83K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 02/20/2019
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/17/2018; 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1