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

Model Number BML-V442QR-30

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been returned to olympus, but has not yet been evaluated.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It is reported during a mechanical lithotripsy of a large (approximately 2 cm) common bile duct (cbd) stone using a single use mechanical lithotriptor v, the stone was captured in the basket and on attempting to crush it, the wires of the basket snapped in the device using the regular lithotriptor handle.The wires were then fed through a rescue sheath and rescue handle.Upon tightening the wires, they again snapped in the rescue handle between the winding device and the front of the handle.The procedure was later completed in a separate surgery to remove stones, and remove device fragments.The patient did not experience any adverse effects due to the retained device fragments.The patient's current status is reported to be stable.

Manufacturer Narrative

This report is being updated to provide investigation results.New information is reported in h3, h6 and h10.Corrected information: h6 health effect: impact code the device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Physical evaluation of the returned device reveals: only basket wire was returned.The basket portion and the wire of the operation pipe side were not sent back for investigation.The length of the wire was about 900mm.The wire was broken at about 200 mm and 1100mm from the distal end.The surfaces of the broken areas of the basket wire indicated that the areas were stretched and then broken.All operation wire outer diameter were measured.No abnormalities were detected.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported 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.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.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.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.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.The operation of the mechanical lithotriptor bml-110a-1 is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard and the basket wire or mechanical lithotriptor is damaged, lithotripsy cannot be continued.Use the bml-110a-1 with the understanding that its basket wire could become damaged and that open surgery may have to take place.If the calculus is too hard, it is possible that the damages shown below (see figures 5.1, 5.2 and 5.3) and other damages may have occurred.In addition, before using the bml-110a-1,thoroughly review its instruction manual and use it as instructed.Conclusion: based on the available information, the following is the likely cause of the reported event: 1) due to issues possibly stemming from the size, shape, hardness or number of calculus, or from the amount of force applied when closing the basket wire, excessive force was required to execute the calculus lithotomy procedure.Due to this, the ?wire/pipe broke.

• 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: 11219456
• MDR Text Key: 230777198
• Report Number: 8010047-2021-01752
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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: 04K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ED34-I10T ,4.2, MAJ-441, BML-110A-1,MAJ-403
• Patient Outcome(s): Required Intervention