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

Model Number BML-V442QR-30

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection of the device¿s distal end found the rubber tip (where to insert the guidewire) to be missing.The missing rubber tip was not returned.The basket, insertion portion, and pipe are still intact and found functional.Based on the investigation findings and similar reported event, the cause of the reported event can be attributed to user error.The instruction manual warns users ¿when using the guide wire, insert the instrument with its distal tip in parallel with the guide wire.Careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire as this may damage the distal tip.Also, do not crush the calculus while the guidewire remains in the distal tip.This may also damage the instrument.¿.

Event Description

Olympus was informed that during an unspecified procedure, the rubber tip on the end of the mechanical lithotripter detached and fell into the patient.It was reported that the device fragment was retrieved.The intended procedure was completed with a similar device.There was no patient injury reported.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6806140
• MDR Text Key: 83747336
• Report Number: 2951238-2017-00544
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2017

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: No Information
• 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: 08/15/2017
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/18/2017
• 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