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

Model Number KD-650L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During a esd(endoscopic submucosal dissection), the subject device(kd-650l) and fd-412lr were used by two operators.When one operator activated the subject device, the another operator who held fd-412lr was burned on the right arm.Treatment was not necessary for that burn injury.The intended procedure was completed with the subject device and fd-412lr.There was no other injury reported.

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.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking delivery record, we assumed the lot number is 7yk.The manufacturing record of the lot 7yk was reviewed and found no irregularities.This type of the event is most likely related to the operator's technique.Omsc presumes that the event occurred due to the following causes.When the operator who held the kd-650l activated output, the distal end of the fd-412lr which was held by another operator contacted with the distal end of the kd-650l.The handle of the fd-412lr or the gloves of the operator who held the fd-412lr were wet with conducting solution.High-frequency current was conducted through conductive solution such as saline.-the electrical cable which connected the kd-650l and the generator touched the operator who held the fd-412lr.The instruction manual of the device has already warned as follows; *when the instrument is used simultaneously with other accessories compatible with high-frequency current, do not activate output while the accessory is in contact with body cavity tissue or with this instrument.This may cause bleeding or thermal injury of the non-target tissue.*aspirate fluids such as mucus that adhere to the tube and body cavity tissue.Patient injury such as perforation, bleeding, mucous membrane damage and thermal injury of tissue could result if output is activated with these fluids adhering.

• 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
• MDR Report Key: 7291557
• MDR Text Key: 100757543
• Report Number: 8010047-2018-00307
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: PK092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-650L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other