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

Model Number KD-650Q

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

Patient Problem Blood Loss (2597)

Event Date 03/12/2015

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp (omsc) for evaluation, because it was already discarded.The lot no.Was unknown, therefore, as the result of checking the manufacturing record of one year in the past from march 12, 2014 (delivery date), there was nothing abnormal detected.The exact cause could not be conclusively determined.However, based on the reported situation, omsc presumes that the event occurred due to any of the following possible causes.The tissue was deeply dissected more than necessary.The large blood vessel was damaged during a dissection.The instruction manual of the subject device warns; do not resect tissue too deep.Deep resection of tissue may cause bleeding, perforation, pneumomediastinum and/or aerodermectasia during or after the procedure.When resecting tissue, confirm that there is no irregularity in the resecting area and monitor the patient's condition all the time.

Event Description

During a colorectal endoscopic submucosal dissection, there was bleeding when dissecting the tissue.The doctor attempted to stop the bleeding with the hemostatic forceps.However the couldn't stop the bleeding because there was excessive bleeding.The patient was shifted to the laparotomy and the bleeding was stopped.The patient was hospitalized, and he is in recovery at present.

• 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: 6104776
• MDR Text Key: 59968156
• Report Number: 8010047-2016-01491
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: KD-650Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Other