MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION SINGLE USE 3-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0720

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The cause of the reported event could not be conclusively determined at this time.The instructions for use warns users: "since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong.When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct and/or damage of the endoscope could result." if additional information is received or if the device is returned at a later time, this report will be supplemented.

Event Description

Olympus was informed that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician introduced the device into the patient to cannulate the bile duct.Once the bile duct was cannulated and the physician was about to cut the sphincterotome, the wire was noted to be broken on the device.The device was removed from the patient and another similar device was used to complete the intended procedure.It is unknown if x-ray was performed to see if a device fragment was left inside the patient.There was no patient injury reported.No additional information was provided.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME
• Type of Device: SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5264759
• MDR Text Key: 32816114
• Report Number: 2951238-2015-00592
• Device Sequence Number: 1
• Product Code: FDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: KD-V411M-0720
• Device Catalogue Number: KD-V411M-0720
• Device Lot Number: 54K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• 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