MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

Model Number KD-VC631Q-07201S

Device Problems Break (1069); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received or if the device is returned for evaluation at a later time, this report will be supplemented.

Event Description

Olympus was informed that during an endoscopic retrograde cholangiopancreatography (ercp) procedure, when the cautery foot pedal was activated, the device sparked and broke off inside the patient.The physician immediately removed the device fragment from the patient.A non-olympus cautery unit was used with the reported device and was set on endocut.The settings were at 200 cut and 40 coag.There was no patient injury reported; however the patient was reportedly moving around excessively on the table.The procedure was completed using a different but similar device.No additional information provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The device was returned to olympus for evaluation.A visual inspection on the received condition of the device found thermal damage on the end of the cutting wire.The tip of the cutting wire at the distal end green marker measured at approximately 2mm in length.The remaining broken cutting wire retracted inside the insertion portion of the device.After manipulating the handle, the cutting wire extended out from the insertion portion and confirmed no missing parts.The entire length of the insertion portion was found with no irregularities and the handle was functioning properly.The exact cause of the reported phenomenon could not be conclusively determined; however, the most likely cause can be attributed to the operator's technique.The instruction manual contains several warning statements in an effort to prevent damage to the sphincterotome."do not use excessive force to bend the distal end of the sphincterotome.Do not operate the sphincterotome if the insertion portion is bent or the distal end of the tube is straight.Do not operate the guidewire in the tube of the sphincterotome unless the distal end of the guidewire is wet.Do not move the slider rapidly.Do not stretch the cutting wire too tightly.Do not rotate the handle with regard to the insertion portion.This could damage the tube and sphincterotome.".

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
• 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: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5105529
• MDR Text Key: 26806982
• Report Number: 2951238-2015-00459
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: KD-VC631Q-07201S
• Device Catalogue Number: KD-VC631Q-07201S
• Device Lot Number: 54K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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