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

Model Number KD-640L

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause could not be conclusively determined.A supplemental report will be submitted, if additional and significant information becomes available at a later time.

Event Description

During a per-oral endoscopic myotomy, the nurse found that the fluid was flowed back through the sheath of the subject device from the patient.Also, the nurse felt electrical stimulation three times on the handle of the subject device.The procedure was completed with the subject device.No injury except for electrical stimulation was reported.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2016-10126 to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There were no defects on the subject device.The tissue adhered on the cutting knife, the triangle tip and the slider of the subject device.As the result of checking the manufacturing record of the same lot, there was nothing abnormal found.Based on the evaluation and similar cased in the past, the nurse might feel electrical stimulation since high frequency flowed to the nurse through the tissue adhered on the slider.The tissue might adhere to the slider when the subject device was inserted to the endoscope or withdrawn from it.The instruction manual of the subject device already states; should the slightest irregularity be suspected, do not use the instrument or a cord; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforation, bleeding, mucous membrane damage or thermal injury and may result in more severe equipment damage.

• 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
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6203822
• MDR Text Key: 63259481
• Report Number: 8010047-2016-10126
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-640L
• Device Lot Number: K6719
• Other Device ID Number: 04953170208423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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): Other