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

Model Number	FD-411UR
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During an unspecified procedure, the subject device was used.In the procedure, the subject device did not activate output when stepped on the foot switch.There was no patient injury reported.The subject device was discarded by the user.No further information was provided.This is the report regarding the failure of the output.
Additional 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, because the subject device was discarded by the user.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 subject device was not connected to the cord or the cord was not connected to the power supply correctly.The contact condition between the patient and the patient plate was bad.The current density decreased because the target area was immersed in blood or water.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 9614136
• Report Number: 8010047-2020-00971
• Device Sequence Number: 19513430
• Product Code: KNS
• UDI-Device Identifier: 04953170251542
• UDI-Public: 04953170251542
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: FD-411UR
• Device Lot Number: 99K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1