MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORP. OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2014

Event Type  malfunction  

Event Description

Olympus was informed that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, when the basket was opened in the bile duct, the basket wires separated but did not detach.The device was safely removed from the pt.The procedure was completed with an olympus balloon.There was no pt injury reported.

Manufacturer Narrative

The device has not been yet returned to olympus for evaluation.The exact cause of the user's report could not be conclusively determined.A supplemental report will be submitted, if additional and significant info becomes available later.

• Brand Name: OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEM CORP.; 2951 ishikawa-cho; hanchioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3784929
• MDR Text Key: 16687357
• Report Number: 2951238-2014-00051
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/22/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: BML-V442QR-30
• Device Catalogue Number: BML-V442QR-30
• Device Lot Number: 3YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/07/2014
• 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