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

Model Number BML-V242QR-30

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report the user's experience and investigation findings.The device was not returned to olympus for evaluation (since it was exposed to a patient with infectious diseases), there for a physical examination of the complaint device could not be performed.The lot was not provided and the manufacture date cannot be identified since the subject device was not returned.The device history records below were reviewed for the lots 16k through 25k since the lot number of the device was not provided.The review revealed the lots had passed all the inspections relating to the reported incident.These lots were manufactured one year before the event date.Process inspection sheet reviewed.Quality inspection sheet reviewed.Nonconforming product report reviewed.The instruction manual contains a warning to the user regarding this event.(drawing number: gk5897, revision number : 20) before use, thoroughly review the method of use for this instrument and bml-110a-1 in accordance with the instruction manuals.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.Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case the calculus cannot be crushed by lithotripter bml-110a-1.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.Before each case, prepare and inspect the instrument and bml handle as instructed below.Inspect other equipment to be used with the instrument and bml handle as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use the instrument or bml handle; contact olympus.Damage or irregularity may compromise patient or user safety, which poses an infection control risk, and can cause tissue irritation, perforation, bleeding or mucous membrane damage and may result in more severe equipment damage.Never use excessive force to operate the instrument and bml handle.This could damage the instrument and/or bml handle.Keep pliers or wire cutters so that you can cut the instrument if it is damaged.Also have the olympus bml-110a-1 lithotriptor ready.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 this instrument by considering that it may lead to damage of 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 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.During lithotripsy, keep the portion from the coil sheath to the bml handle straight in line with the scope¿s biopsy valve, as much as possible.If not straight, the coil sheath may bend, calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body.Do not rotate the bml handle knob abruptly.This instrument may break, and/or calculus may not be crushed.Also, the instrument with calculus engaged may not be removed from the body.Lower the endoscope¿s forceps elevator when performing lithotripsy.If lithotripsy is performed when the elevator is not lowered, the scope or the instrument may break and/or the calculus may not be crushed.Also, the instrument with calculus engaged may not be removed from the body.If the calculus is too hard and the instrument is damaged as described on pages 58 ¿ 63, it may be necessary to use the bml-110a-1.In this case, also refer to the instruction manual for the bml-110a-1.Conclusion: the exact cause of the problem could not be identified, since the device was not retuned for investigation.From the investigation results in the past, due to various factors such as the size, hardness or shape of the calculus, a load beyond the resistance strength might have applied to the product during the lithotripsy.As a result, the operating pipe and/or operating wire was possibly broken and the device could not be retracted.

Event Description

The customer reports during an endoscopic retrograde cholangiopancreatography (ercp) with common bile duct (cbd) stone retrieval using a single use mechanical lithotriptor v, the device was used to crack a large stone, but the basket was accidentally jammed within the common bile duct.Even though the emergency mechanical lithotriptor was used, the basket still could not be removed.The patient was taken to the operating room where a boston scientific spyglass was used to remove the incarcerated device.The patient was discharged.No additional consequences to the patient were reported.The subject device cannot be returned for evaluation, the facility will not allow it to be taken out of the hospital because it was used for a patient with infectious diseases.Additional details regarding the patient/event were requested.This information could not be provided due to hong kong privacy regulations.

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14956676
• MDR Text Key: 295492194
• Report Number: 8010047-2022-11579
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218392
• UDI-Public: 04953170218392
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2022

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-V242QR-30
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/08/2022
• 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; Required Intervention