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

Model Number BML-V237QR-30

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

Patient Problem No Code Available (3191)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.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.The user tried to crush calculus about the size of 20 mm but could not crush it.The user tried to crush the calculus with the emergency lithotriptor.The basket wire was broken off and the user became unable to use the emergency lithotriptor any further.The user could not remove the subject device from the patient body.The user left the broken device inside the patient with the broken basket wire covered with a stent for endoscopic nasobiliary drainage and completed the procedure.It was reported that the additional treatment was planned at a later date.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The operation wire was cut at 70 mm from the distal end.The operation wire was broken off at 940 mm from the distal end.The broken surface showed that mechanical tensile load was applied.There was no abnormality in the outer diameter of the three operation wires.The operation wire was broken off at 2000 mm from the distal end.The broken surface showed that mechanical tensile load was applied.There was no abnormality in the outer diameter of the three operation wires.The basket wire was deformed.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.1) due to factors such as the quantity, size, shape, hardness of calculus, or strength of the force to close the basket wire, more force than expected was applied to the device when the stone was gripped.2) due to 1), the operation wire near the operation part was broken.3) when the user tried to crush stones using bml-110a-1, due to the factors such as the quantity, size, shape, hardness of calculus, or strength of the force to close the basket wire, more force than expected was applied to the device.4) due to 3), the middle part of the operation wire was broken.The above device handling has warned in the instruction manual.

• 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: 10446307
• MDR Text Key: 208992525
• Report Number: 8010047-2020-05779
• 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: 11/13/2020

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-V237QR-30
• Device Lot Number: 9YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR