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 Twisted/Bent (2981); Material Split, Cut or Torn (4008); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.

Event Description

The service center received a report of a single use preloaded sphincterotome v ( model kd-vc631q-07301a), lot number 9yv, that came apart during a procedure.The physician was performing an endoscopic retrograde cholangiopancreatography (ercp) when inserting a guidewire into the device it came out of the side of the tome, last 15-20 cm and the cannula was stripped.This reported incident occurred at the beginning of the procedure.The intended procedure was completed with no delay and with a new device.It was reported no items fell into the patient, and there was no patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation and the correction for the lot number and manufacture date.The single use preloaded sphincterotome v (model kd-vc631q-07301a), lot number 9yv 06, was received at the service center for the evaluation for ¿ had stripped, and came out of the side of the tome¿.The user¿s complaint was confirmed.A visual inspection was performed on the received condition device and observed that the insertion portion of the sheath was split open and twisted, which caused the wire to be exposed below the handle side.The insertion portion sheath below the handle was noted to be kinked which increased the stress and tension to the wire during manipulation of the slider.The noted observation resulted the wire splitting the insertion sheath and allowed the guide wire to come out while inserting.Based upon evaluation of the returned condition of the device, the cause of the kinked/twisted/split insertion portion sheath is due to the excessive stress and force attributed to mishandling.

• 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
• MDR Report Key: 9689123
• MDR Text Key: 221305072
• Report Number: 8010047-2020-01211
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170371516
• UDI-Public: 04953170371516
• Combination Product (y/n): N
• PMA/PMN Number: K141991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: KD-VC631Q-07301A
• Device Lot Number: 9YV 06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1