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 Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The mechanical lithotriptor was not returned to the service center for evaluation.The cause of the reported event could not be determined; however, this type of device malfunction could be attributed to the operator¿s technique.The instruction manual contains warning and caution statements in an effort to mitigate damage to the lithotriptor device.Chapter 5 emergency treatment.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.If lithotripsy can no longer be performed, follow the procedures described in this chapter.If there is little resistance from the bml handle¿s rotatable knob, the instrument may be damaged and lithotripsy may not be possible.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.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during an endoscopic retrograde cholangiopancreatography (ercp) procedure, the mechanical lithotriptor wires popped out and broke.The emergency handle was used to recover the device fragment.The procedure was delayed 15 minutes.There was no patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was inspected.There was no damage or abnormalities observed.The delay was caused by the breakage of the device and having to retrieve it from the patient.The patient was not under anesthesia.A lithrotripsy was being performed when the wires popped out and broke.This occurred in the middle of the procedure.The customer's title is not available.Another action item will be sent for clarification.Update: that no parts fell inside the patient as per the customer.The basket's wires broke , without any pieces falling inside the patient, and that has caused the delay in procedure ( setting up the emergency handle, etc), as per the client.The handle used to remove the wire was an olympus bml- 110a the lot number is unknown.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.Lm reported that the most probable cause for the reported event is as follows: based on similar cases in the past, the basket wire might have broken by the following mechanism: due to various factors such as the shape, numbers, hardness of the calculus, and the magnitude of the force necessary to close the basket wire, it can be inferred that a force larger than expected might have been applied to the device while the basket wire was grasping the calculus.Content of the instruction manual (drawing number: gk5909, revision number :20) was confirmed.The instruction manual contains the following descriptions, and it warns against this event.·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.·never use excessive force to operate the instrument and bml handle.This could damage the instrument and/or bml handle.·do not open and close the basket too quickly.Doing so could damage 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.·do not use this lithotriptor bml-110a-1 for a calculus that is assumed impossible to be crushed by this lithotriptor.The basket wire etc.May break and part of this lithotriptor may remain in the body.

• 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
• MDR Report Key: 11313505
• MDR Text Key: 233562617
• Report Number: 8010047-2021-02524
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• PMA/PMN Number: EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2021

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 Lot Number: O4K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 02/25/2021; 04/27/2021
• Supplement Dates FDA Received: 03/19/2021; 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1