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

Model Number BML-V437QR-30

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 12/25/2020

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During a lithotrity, the subject device was used.It was reported that the shaft which was connected to the handle was broken off since the calculus was hard.The user became unable to remove the subject device, and switched to the open surgery.Patient had good prognosis.Two devices were returned to olympus medical systems corp.(omsc) for evaluation.Both devices were broken.This is the report on the second device.

Manufacturer Narrative

This is a supplemental report to provide additional information.It was additionally reported that two devices were used for the same procedure.The first device was broken but could be removed from the patient.The user exchanged it for the subject device and continued the procedure.The user became unable to remove the subject device, and switched to the open surgery.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Since the device was severed, it was unable to identify the name of the product and lot number.The subject device had been severed at 1340 mm from the distal end of the insertion portion.The black tube at the insertion portion presented compressive buckling in several places.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the event date, it was found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.1) due to various factors such as the shape, numbers, hardness of the calculus, and the magnitude of the force necessary to close the basket, it can be inferred that a force larger than expected might have been applied to the device while the basket was grasping the calculus.2) due to in state of ¿1¿ description, the basket became unable to be removed.When an attempt was made to crush the calculous, an excessive compression load might have been applied to the coil sheath and the coil, causing misalignment of the coil and compressive buckling.The above device handling has warned in the instruction manual as follows.*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.*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.*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.

• 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: 11213280
• MDR Text Key: 228943561
• Report Number: 8010047-2021-01708
• Device Sequence Number: 1
• Product Code: LQC
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V437QR-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention