MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number KD-650L

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical system corp.(omsc) for evaluation.It was confirmed that the distal end of the cutting knife was broken off.Also, the distal end of the cutting knife was missing and the broken section was melted.The manufacturing history record was reviewed, with no irregularities noted.Based on the similar cases in the past, it is assumed that the distal end of the cutting knife broke off due to the following mechanism.An electric discharge was generated because the cutting knife and the tissue contacted at points or came close to each other during activation.Then, the strength of the cutting knife was deteriorated due to local increase of the heat given to the cutting knife.Since the cutting knife was subjected to a load, such as when it was pushed against the tissue, the cutting knife was deformed.Moreover, it is assumed that the cutting knife broken off and the broken section was melted since the high heat generated due to the influence of the electric discharge.The instruction manual of the device has already warned as follows; when the electrosurgical unit is used in the coagulation mode, deformation or 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 deformation or 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 coated outer tube.Do not continue using an abnormal electrosurgical knife to prevent perforation or bleeding.If the cutting knife is detached, be sure to collect it using grasping forceps.

Event Description

During endoscopic submucosal dissection, the subject device was used.When the doctor checked the subject device after the procedure, the cutting knife of the device was bended.There was no patient injury reported.No information other than the above was reported.When the device was evaluated on (b)(6) 2017, it was found that the distal end of the cutting knife was broken off.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6954048
• MDR Text Key: 90556219
• Report Number: 8010047-2017-01484
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: KD-650L
• Device Lot Number: 76K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1