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

Model Number BML-V232QR-30

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The operating wire was broken at several parts.The broken point at 1246.3mm from the distal tip was ductile fracture.There were some slips on the coil sheath.The outer diameter of the operating wire was found no irregularities.The junction between the operation pipe and the operating wire was broken but there was no abnormality in the brazing condition of the junction.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the subject device was incarcerated since the basket wire was subject to a load due to the hardness, size or shape of the calculus and the junction of the operation wire and the operation pipe was broken.It was known that the breakage of the basket wire might have occurred since the operating wire was subject to a load due to the hardness, size or shape of the calculus during using the emergency handle.The instruction manual of the device has already warned as follows; 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, tube sheath not completely retracted in coil sheath etc.).Stop use when any abnormality is detected.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.

Event Description

During an endoscopic mechanical lithotripsy, the subject device was used.In the procedure, the subject device was incarcerated.The physician tried to crush the calculus with the emergency handle, but the basket wire broke.The distal part of the basket wire was broken off and fell into the patient body.The operator placed the plastic stent and completed the procedure.It was reported that the patient would be transformed to another hospital in order to receive a procedure since the calculus was massive and could not be crushed.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8163547
• MDR Text Key: 130314427
• Report Number: 8010047-2018-02433
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/14/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: BML-V232QR-30
• Device Lot Number: K6Y02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2016
• 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
• Patient Outcome(s): Hospitalization