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

Model Number BML-V232QR-26

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 11/25/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was discarded by user facility and could not be returned.The exact cause of the user¿s report could not be conclusively determined.As a result of the checking the manufacturing record of the lot for the year from the delivery date due to the unknown lot, nothing abnormal was detected.Process inspection sheets; quality inspection sheets.Based on the similar cases in the past, it is likely that crushing the calculus failed due to hardness or shape of the calculus, and the basket wire remained biting into the calculus, causing the subject device to get stuck in the bile duct.In addition, the cause of damaging the bile duct resulting in open surgery is presumed to be a forcible and abrupt withdrawing of the subject device from the bile duct with stone engaged.The device instruction manual has warned users that there is possibility the calculus cannot be crushed by lithotriptor, and it also describes what to do if the lithotriptor cannot crush the calculus.The device instruction manual also warns not to withdraw this instrument with stone engaged from the bile duct abruptly and/or with excessive force.This could cause perforation, bleeding, mucous membrane damage or edema.Warning: 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.If the calculus is too hard, it is possible that the damages shown in chapter 5, ¿emergency treatment¿ may occur.Use the lithotriptor by considering that it may lead to damaging the instrument and that open surgery may have to take place; 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 ithotripsy 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, tube sheath not completely retracted in coil sheath etc.).Stop use when any abnormality is detected; do not withdraw this instrument with stone engaged from the bile duct abruptly and/or with excessive force.This could cause perforation, bleeding, mucous membrane damage or edema; do not push the bml handle¿s holder abruptly, as it may cause the basket to open abruptly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the endoscope and/or instrument; do not turn the bml handle¿s holder forcibly when the basket does not rotate in any direction, although the rotation handle is turned.Otherwise, the basket will rotate suddenly.This could cause perforation, bleeding or mucous membrane damage.It may also damage the endoscope and/or instrument.

Event Description

Olympus medical systems corp (omsc) was informed that during crushing calculus inside the bile duct, the physician could not crush it and remove it from the basket on (b)(6) 2016.The physician attached the basket wire of this device to the mechanical lithotriptor handle (bml-110a-1).The calculus was crushed.The physician completed the procedure.However, bleeding due to the subject device was confirmed in the bile duct, and the procedure was shifted to emergency open surgery.The patient is recovering.

• 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: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6306265
• MDR Text Key: 66658087
• Report Number: 8010047-2017-00124
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial

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: No Information
• Device Model Number: BML-V232QR-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/06/2017
• 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
• Patient Outcome(s): Other