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

Model Number KD-V411M-0720

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

The subject product was returned to omsc for investigation.The investigation confirmed that the coating on the cutting wire was torn and the cutting wire was broken.The broken section was melted and burned.The length of the coating was approximately 10.0 mm shorter than the specification.There were no other abnormalities related to the breakage in the subject device.As the checking of the manufacturing record of the same lot, nothing abnormal was detected.The length of the cutting wire.The length of coating on the cutting wire.Outer appearance of coating on the cutting wire.Movement of the cutting wire.This type of damage is most likely related to the operator's technique.As the results of the investigation, omsc assumes that the damage of the coating and cutting wire occurred due to contacting with the metal part of the forceps elevator of the endoscope.The exposed cutting wire from the damaged coating contacted or came close to the metal part of the forceps elevator while activating the output, which caused spark and a part of the cutting wire became extremely hot, resulting in breakage.The coating broke off and came off from the cutting wire because of the user handling after the cutting wire was broken.

Event Description

Olympus medical systems corp (omsc) was informed that during clinical treatment, knife wire was broken immediately after energization.The doctor exchanged the subject device for another device and completed the procedure.There was no patient injury reported.The subject product was returned to omsc for investigation on (b)(6) 2016.The investigation confirmed that the coating on the cutting wire was torn and the cutting wire was broken.The broken section was melted and burned.The length of the coating was approximately 10.0 mm shorter than the specification.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SPHINCTEROTOME
• 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: 6184690
• MDR Text Key: 62678316
• Report Number: 8010047-2016-01583
• 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: Other
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: KD-V411M-0720
• Device Lot Number: K6728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2016
• 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