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

Model Number KD-611L

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2011

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The distal tip was broken.As the result of checking the manufacturing record of the same lot, there was nothing abnormal found.Based on the similar cases in the past, it was known that the distal tip might be broken, since electric discharge occurred and temperature of the distal tip increased while the high frequency output was activated.Also, it was known that electric discharge might occur, because the electro surgical unit was used in the coagulation mode, the high frequency setting value was too high, the activation time was too long, or the contact length between the cutting knife and the tissue was too short.The instruction manual of the subject device warns; when the electrosurgical unit is used in the coagulation mode, crack/detachment of the tip and the electrode or deformation/break of the cutting knife could occur, for example when the high-frequency output is set too high or the length of the contact between the cutting knife and tissue is too short.During treatment, always ensure that the slider slides on the handle smoothly and that the electrosurgical knife observed in the endoscopic image is normal.Should cracks or detachment of the tip or deformation/break of the cutting knife be detected during use, immediately shut off the power supply, discontinue the procedure, pull the slider and withdraw the endoscope from the patient with the cutting knife retreated in the insertion portion of this instrument.Do not continue using an abnormal electrosurgical knife to prevent perforation or hemorrhages.If the tip or cutting knife is detached be sure to collect it using grasping forceps.

Event Description

Olympus medical systems corp.(omsc) performed a mdr retrospective review and found that this report was required.During an endoscopic submucosal dissection, the doctor coagulated the tissue with the subject device.After that, he withdrew the subject device once, and he inserted it again.Then the distal tip of the subject device was broken, and a part of it was fallen off into the patient.The doctor retrieved the fragment.No patient injury was reported.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6207666
• MDR Text Key: 63369842
• Report Number: 8010047-2016-01616
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-611L
• Device Lot Number: K1808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2011
• Date Manufacturer Received: 10/19/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1