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

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem Perforation (2001)

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

The device in this report was not returned to olympus for evaluation.The cause of the reported event could not be determined.However, the most likely cause of the reported event is attributed to user handling.The instruction manual contains warning and caution statements in an effort to prevent damage to the lithotripter device."do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotriptor.The pipe or the basket wire may break and part of this instrument may remain in the body.A lithotriptor cannot always crush all calculi captured in the basket.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure.".

Event Description

Olympus was informed that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the lithocrush basket broke at the handle outside of the patient when the surgeon was crushing a stone.The size of the stone is unknown.The basket wires did not break inside the patient.An emergency handle and sheath was then used to try and remove the lithocrush inside the patient.The wires that were inserted in the emergency handle broke from the handle and struck the surgeon's left thumb.The surgeon was x-rayed and a bandage was applied.In addition, a total loss of image was experienced.The intended procedure was completed using non-olympus devices.A boston scientific spyglass and a dilating cook balloon were used to remove the stone from the patient.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: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5565145
• MDR Text Key: 42266452
• Report Number: 2951238-2016-00356
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: BML-V442QR-30
• Device Catalogue Number: BML-V442QR-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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