MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number BML-V437QR-30

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2023

Event Type  Injury  

Event Description

The olympus representative reported on behalf of the customer that during the endoscopic retrograde cholangiopancreatography (ercp) procedure (therapeutic), the single use mechanical lithotriptor v fractured during lithotripsy and the tip fell off.The broken point was the base of the basket.The operating side part of the stone crusher was cut, and the scope was removed once and reinserted.After that, the bile duct was expanded with a balloon, and the removal of the basket was completed.There was a forty-five minute procedure extension.The procedure was completed using the same set of equipment.There were no reports of health hazard associated with this event.

Manufacturer Narrative

The device was returned and evaluated, and the customers allegations were confirmed; the operating wire and the operating pipe were removed from the sheath; the operating pipe was broken at the brazing joint of the operating wire; the basket wire was deformed; and misalignment of the coil was observed at the distal end of insertion portion of the coil sheath.The brazed condition of the broken portion presented no abnormalities, and the outer diameter of the broken portion was measured and the result indicated no abnormalities.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.It has been almost 1 year since the subject device was manufactured.The subject device was shipped in accordance with specifications.Based on the results of the investigation, the root cause of the reported phenomenon could not be identified.However, a likely mechanism causing the events might be the following: various factors such as the shape, numbers, hardness of the calculus, and/or a force beyond the strength resistance may have been applied to the device during the lithotripsy.This could have led to deformation of the basket and misalignment of the coil sheath, and the operating pipe becoming broken at the brazing joint.As a result, this may have caused the inability to remove the basket portion from the patient's body.The instruction manual of the subject device contains the following descriptions.Do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotripter.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 lithotripter 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 lithotripter 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 lithotripter bml-110a-1 for a calculus that is assumed impossible to be crushed by this lithotripter.The basket wire etc.May break and part of this lithotripter 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 lithotripter 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 lithotripter 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 may have occurred.In addition, before using the bml-110a-1,thoroughly review its instruction manual and use it as instructed.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17132172
• MDR Text Key: 317208136
• Report Number: 9614641-2023-00848
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218415
• UDI-Public: 04953170218415
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2023

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-V437QR-30
• Device Lot Number: 27K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2023
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2022
• 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
• Treatment: JF-260V (SERIAL: (B)(6))
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Race: Asian