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

Model Number	KD-VC631Q-07301A
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Material Split, Cut or Torn (4008); Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sphincterotome v (kd-vc631q-07301a) device has not been returned to the service center for evaluation as it has been reported to have been discarded by the user facility.Therefore, the exact cause for the guide wire protruding through the tome cannot be determined; if the device is returned, an evaluation will be conducted and a supplemental report will be submitted.
Event or Problem Description
The service center received a report of five single use sphincterotome v devices (model kd-vc631q-07301a), all from lot number 9yv, that upon insertion of the guidewire, it went through the side of the tome during an unspecified procedure.It was reported that all five devices malfunctioned in the same manner.This is for the second kd-vc631q-07301a device reported.It was reported that the intended procedure was completed with a new device and there was no patient injury.The device was discarded upon completion of the procedure and will not be returned to the service center for evaluation.This is report 2 of 5.

• 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: 9734780
• Report Number: 8010047-2020-01468
• Device Sequence Number: 3320306
• Product Code: KNS
• UDI-Device Identifier: 04953170371516
• UDI-Public: 04953170371516
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: Health Professional
• Device Model Number: KD-VC631Q-07301A
• Device Lot Number: 9YV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1