MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. OLYMPUS SINGL USE MECHANICAL LITHOTRIPTOR V; MECHANICAL LILTHOTRIPTOR

Model Number BML--442QR-30

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 05/28/2014

Event Type  Injury  

Event Description

Olympus was informed that during a biliary tract procedure, the user attempted to retrieve a non-olympus balloon inside the patient; however, the device failed to retrieve the balloon.The patient was reported to have undergone an open surgery to resolve the issue.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the user's experience could not be conclusively determined at this time.However, based on the information provided, the reported phenomenon appears to be due to user error, as the device was used off-label.The bml-v442qr instruction manual intended use section states: "this instrument has been designed to be used with an olympus endoscope for crushing calculi inside the bile duct.Do not use this instrument for any purpose other than its intended use".If additional information or if the device is received at a later time this report will be supplemented.

• Brand Name: OLYMPUS SINGL USE MECHANICAL LITHOTRIPTOR V
• Type of Device: MECHANICAL LILTHOTRIPTOR
• Manufacturer (Section D): OLYMPUS AMERICA, INC.; 2591 ishikawa-cho,; hachioji0-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho, hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131-1700 ; 4089355002
• MDR Report Key: 3934877
• MDR Text Key: 4574351
• Report Number: 2951238-2014-00239
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BML--442QR-30
• Device Catalogue Number: BML-V442QR-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention