MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN NEEDLE KNIFE V

Model Number KD-V441M

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

As a result of evaluating the subject device, the cutting knife was burnt as it was pointed out.The wire extension of the cutting knife was as the standards.As checking the manufacturing record of the same lot for the subject device, nothing abnormal related to the reported event was detected on the following items.Dimensions of each part for the cutting knife; external appearance of the cutting knife.It is considered the spark (electric discharge) might occur by the following factors.The output was concentrated into one point because the contact length with the tissue was short.The output was performed by "coagulation" mode.The output setting value was high.For the factor of the burnt cutting knife, it is considered the tissue and mucus, etc.Which were stuck to the cutting knife were carbonized by high frequency cauterization.

Event Description

During est, the subject device was used for precutting of a papilla due to the difficulty of cannulation into the bile duct.However, the cutting knife sparked, leading to a half-burnt cutting of the tissue.When the subject device was withdrawn, it was observed that the cutting knife was burnt.The cannulation into the bile duct was impossible, so the procedure was discontinued.

• Brand Name: SINGLE USE 3-LUMEN NEEDLE KNIFE V
• Type of Device: SINGLE USE 3-LUMEN NEEDLE KNIFE V
• 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 ; 42 6425117
• MDR Report Key: 5781445
• MDR Text Key: 49125343
• Report Number: 8010047-2016-00869
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950166
• 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: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: KD-V441M
• Device Lot Number: K6414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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