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 Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

The lithocrush device was reported discarded by the user facility and will not return to olympus for evaluation.The cause of the customer complaint cannot be confirmed.A potential cause for the dislodged tip is excess applied force.The instruction manual contains warnings and cautions to prevent mechanical damage: ¿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.¿ and ¿insert the instrument slowly.¿ the instruction manual also has directions for pre-procedure visual inspection and operational exercise of the device.As a preventive measure in the event of device malfunction, the instruction manual also advises to always have a spare device available during the procedure.

Event Description

Olympus was informed that during an ercp procedure for removing common bile duct stones, the plastic tip detached and fell onto the basket wire and possibly into the patient.The detachment occurred while the basket was extended but before the device engaged with the stones.The clinician lost track of the tip.It was reported that the tip may have been suctioned back into the scope because the scope suction jammed afterwards.There was no reported patient injury and no other damage or breakage to the device.The procedure was completed with another lithocrush device from the same lot.

• 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: 7308572
• MDR Text Key: 101590311
• Report Number: 2951238-2018-00143
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2018

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: 74K
• Other Device ID Number: 04953170218422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/01/2018
• 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