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

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

The reported device was returned to olympus for evaluation.The evaluation confirmed that the rubber tip was missing and that there was no other breakage or damage to the device.The probable cause for the dislodged tip is excess applied force.As a preventive measure in the event of device malfunction, the instruction manual advises to always have a spare device available during the procedure.The instruction manual also contains warnings and cautions to prevent mechanical damage to the device: ¿when using the guide wire, insert the instrument with its distal tip in parallel with the guide wire¿be careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire¿this may damage the distal tip¿.¿never use excessive force to operate the instrument and bml handle.This could damage the instrument and/or bml handle.¿ and ¿insert the instrument slowly.Abrupt insertion may damage the endoscope and/or instrument.¿ the instruction manual also has directions for pre-procedure visual inspection and operational exercise of the device.

Event Description

Olympus was informed that during an ercp procedure to remove a gallstone, the rubber tip fell off the distal end of the device into the patient¿s bile duct, and then migrated down the duodenum where it could not be retrieved.There was no reported patient injury and no other damage or breakage to the device.The procedure was completed with another similar lithocrush device.

Manufacturer Narrative

This supplemental report is being submitted to correct the event date.The event date has been corrected to the event date documented in the service request system.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7134272
• MDR Text Key: 96050793
• Report Number: 2951238-2017-00778
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

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: BML-V442QR-30
• Device Catalogue Number: BML-V442QR-30
• Device Lot Number: 73K
• Other Device ID Number: 04953170218422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1