MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

Model Number	KD-VC611Q-07201S
Medical Device Problem Codes	Sparking (2595); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no additional information of this event available at this time.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.
Event or Problem Description
As reported for this event, during the therapeutic endoscopic retrograde cholangio-pancreatography (ercp) procedure the element incinerated and had sparks occurring during the cutting of papilla.The sparks were not generated by energization nor was the device dropped.No parts peeled or fell off into the patient.There was no adverse impact to the patient or the procedure.The procedure was completed using the same set of equipment.
Additional Manufacturer Narrative
Relevant additional information has been received for this event.This information is being provided in this supplemental report.Please see the updates in sections: g4, g7, h2, and h10.The full procedure name is endoscopic retrograde cholangio-pancreatography (ercp) sphincterotomy with site location the ampulla.The issue took place issue happened within seconds of the procedure starting.The wire was in contact with the tissue when the issue occurred.Settings were: for endocut i, effect 2, cut duration 2, cut interval 3; for forced coag mode, effect 2.
Additional Manufacturer Narrative
The device has not been return so an actual device evaluation is not done.However, evaluation is done with historical records and communication.This supplemental report is being submitted to provide this information.Reported issue for this event, during the therapeutic endoscopic retrograde cholangio-pancreatography (ercp) procedure the element incinerated and had sparks occurring during the cutting of papilla.The device history record review confirmed that there were no abnormalities in manufacturing related to this event.The device was manufactured in february 2019.Two pictures of the device were provided.Therefore, the investigation was implemented on the basis of the picture.There was a tear of the cutting wire near the tube hole at the distal end.A likely cause of the cutting wire tear might be the following.·high frequency current was applied between the cutting wire and the tissue at the point of the contact.As a result, the current density at the contact area increased, and the cutting wire became instantly hot.·high frequency current was applied when the cutting wire and the tissue were being close to each other.As a result, an electrical discharge occurred, and the cutting wire became instantly hot.The instructions for use includes the following statements: 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.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10337768
• Report Number: 8010047-2020-04958
• Device Sequence Number: 11557894
• Product Code: KNS
• UDI-Device Identifier: 04953170371257
• UDI-Public: 04953170371257
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2020

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
• Operator of Device: No Information
• Device Model Number: KD-VC611Q-07201S
• Device Lot Number: 92V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/07/2020; 09/26/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/04/2020; 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1