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

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

The basket was returned to the service center for evaluation.However, the customer did not returned the handle, the wire joint, the whole sheath and injection port is missing from this device.A full evaluation could not be performed due to the missing parts.A visual inspection was performed on the returned basket wire and noted the distal end basket wire was broken off and frayed.In addition, the proximal end of the basket wire was also noted to be broken up and frayed.Based on the reported complaint and investigation, it was determine that the cause of the broken and frayed basket wire was most likely due to excessive stress and force attributed to mishandling.The instruction manual warns users ¿do not forcibly push or pull the sheath or the bml handle during lithotripsy.Perforation, bleeding or mucous membrane damage could result.It may also damage the endoscope and/or the guidewire and/or the instrument.This instrument will deform and/or deteriorate by performing lithotripsy.When lithotripsy is repeated, it will deform and/or deteriorate furthermore.By such deformation and/or deterioration, calculus may not be crushed and/or the instrument with calculus engaged may not be removed from the body.If lithotripsy is required to be repeated in a single case, make sure to check each time that no abnormality is found in action and/or appearance (e.G.Basket wire cut or worn, tube sheath bent, notable coil sheath bent or gap etc.).Stop use when any abnormality is detected.¿ if additional information becomes available, this report will be updated and supplemented accordingly.

Event Description

The service center was informed that during an unspecified procedure, the wire joint of the instrument broke off of the bml handle.The emergency lithotriptor handle was then used to assist with the with retrieval of the broken basket and while utilizing the handle the basket wire broke again.An emergency procedure was performed on the patient to remove the remaining section of the basket.The patient¿s current condition is unknown.

• 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 ; 4089355124
• MDR Report Key: 8693261
• MDR Text Key: 147802996
• Report Number: 2951238-2019-00936
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXMPT
• 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
• Report Date: 06/12/2019

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: Health Professional
• Device Model Number: BML-V442QR-30
• Device Lot Number: 76K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/12/2019
• 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: Initial
• Patient Sequence Number: 1
• Treatment: BML HANDLE V (MAJ-441); EMERGENCY LITHOTRIPTOR HANDLE (BML-110A-1)
• Patient Outcome(s): Required Intervention