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

Model Number	KD-640L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
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 a per-oral endoscopic myotomy, the subject device was used.The distal knife of the subject device fell inside the patient.The fragment was retrieved with a grasping device.The intended procedure was completed with the subject device.There was no patient injury reported.This is the report regarding the falling of the distal knife.
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 cutting knife was broken off at 3.7 mm from the distal end.The fracture surface of the cutting knife showed that it was melted.As a measurement result of the outer diameter of the cutting knife, there was no abnormality.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the temperature of the cutting knife increased and stiffness of the knife weakened since the electric discharge occurred between the knife and the tissue when the user activated high-frequency output, besides the knife was broken off when the knife was subjected to a load during user handling.It was also known that an electric discharge occurred due to the following reasons; the electrosurgical unit was used in the coagulation mode.The high-frequency output was set too high.The activation time was too long.The contact length between the cutting knife and the tissue was too short.The above device handling has warned in the instruction manual as follows.Always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as perforation, bleeding or mucous membrane damage.Application of high-voltage waveforms for extended periods increase the likelihood that it may break the cutting knife or triangle tip.When a high-voltage waveform has to be used, minimize the duration of current application.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8538841
• Report Number: 8010047-2019-01776
• Device Sequence Number: 1743984
• Product Code: KNS
• UDI-Device Identifier: 04953170208423
• UDI-Public: 04953170208423
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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: Health Professional
• Device Model Number: KD-640L
• Device Lot Number: K6X31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1