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

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report has not yet been returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an endoscopic retrograde cholangiopancreatography, lithocrush was used.In the procedure, the user tried to retrieve the calculus with fg-v422pr, but it was incarcerated.When the incarceration was managed using the subject device, the basket wire of the subject device broke off.The surgeon decided to conduct an open surgery to remove the subject device and the calculus.No further information was provided.This is the report regarding the breakage of the basket wire.

Event Description

During an endoscopic retrograde cholangiopancreatography, bml-v442qr-30 was used.In the procedure, the user tried to retrieve the calculus with fg-v422pr, but it was incarcerated.The user tried to crush the calculus with the emergency lithotriptor but the basket wire of the subject device broke off.The user tried to crush the calculus and collect the basket of fg-v422pr using the subject device but the user was not able to get the basket around the stone.The user decided to conduct an open surgery to remove the fg-v422pr and the calculus.No further information was provided.This is the report regarding the switching to the open surgery.

Manufacturer Narrative

This is a supplemental report to provide additional information.From the additional information, the device that was incarcerated and left in the patient body was fg-v422pr and not bml-v442qr-30.The investigation results of fg-v422pr is reported in medwatch #14412.Bml-v442qr-30 was not involved in the incarceration of bile duct stones or additional surgery in this event.Therefore, we are retracting this mdr.

• 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
• MDR Report Key: 8194734
• MDR Text Key: 131371645
• Report Number: 8010047-2018-02548
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/25/2018
• Supplement Dates Manufacturer Received: 01/17/2019; 03/06/2019
• Supplement Dates FDA Received: 02/05/2019; 03/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention