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

Model Number KD-VC631Q-07301A

Device Problems Material Protrusion/Extrusion (2979); Material Split, Cut or Torn (4008); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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 third 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 3 of 5.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Type of Device: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9734807
• MDR Text Key: 209558031
• Report Number: 8010047-2020-01470
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170371516
• UDI-Public: 04953170371516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• 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