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

Model Number KD-611L

Device Problem Device Handling Problem (3265)

Patient Problem Perforation (2001)

Event Date 04/17/2018

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 an endoscopic submucosal dissection, the subject device was used and perforation occurred.The physician closed the perforation with clips and the procedure was completed.

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.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.This type of the event is most likely related to the operator's technique.Based on the past similar cases, it was known that the event occurred due to any of the following possible causes.The high-frequency output was set too high.The activation time was too long.The output was activated when in contact with adhering fluids.Incised the tissue by pressing the knife forcefully more than necessary.The instruction manual of the device has already warned as follows; do not set the output value of the electrosurgical unit too high or too low.Also, do not allow the activation time to be too long or too short.Set the high-frequency output mode of the electrosurgical unit optimally according to the conditions of the tissue to be cut.An excessive or insufficient output value may result in perforation, bleeding, mucous membrane damage or thermal injuries to the non-target tissue.Aspirate fluids such as mucus that adhere to the electrode and/or the cutting knife, outer sheath and body cavity tissues.Patient injury such as punctures, hemorrhages, mucous membrane damage and thermal injury of tissue could result if output is activated when in contact with these adhering fluids.When current is discharged while the cutting knife is being separated from the mucosa under wet situation, it may break the cutting knife or crack the tip.This instrument can be incised by both the cutting knife and the electrode.When incising the tissue by pressing the knife forcefully more than necessary, unintended incision may occur by the electrode part, and it may cause perforation and massive bleeding.Always confirm the direction of incision and do not incise with more pressure than necessary.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7501285
• MDR Text Key: 107821458
• Report Number: 8010047-2018-00797
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-611L
• Device Lot Number: 82K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR