MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS SINGLE USE SPHINCTEROTOME V(DISTAL WIREGUIDED); UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number KD-VC431Q-0720

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/25/2016

Event Type  malfunction  

Event Description

Sphincterotome wire was going to the right instead of the left.

• Brand Name: SINGLE USE SPHINCTEROTOME V(DISTAL WIREGUIDED)
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6367904
• MDR Text Key: 68630001
• Report Number: 6367904
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: KD-VC431Q-0720
• Device Lot Number: 6XK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 43