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

Model Number BML-V232QR-30

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 02/18/2014

Event Type  Injury  

Event Description

Olympus medical system corp.(omsc) was informed that during crushing calculus with the lithotriptor, the subject device was stuck in the patient.The doctor attempted to crush calculus using emergency handle but failed.The basket wire could not be retrieved from the patient.On the day, the doctor performed open surgery and removed calculus and basket wire from the patient.Reportedly the patient was doing well.

Manufacturer Narrative

The coil sheath and part of the cut basket wire were returned to omsc for investigation.However, we couldn't confirm the distal side of the basket wire since it was discarded by the facility.The investigation confirmed that the coil sheath was cut near the handle but there were no abnormalities such as deformations.As the result of checking the manufacturing record of the same lot, there were also no abnormalities noted.The doctor informed us that the calculus was hard.Therefore, omsc considers that the calculus was too hard to crush and it caused this event.The report is being submitted as a medical device report in an abundance of caution.

• Brand Name: OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 3674404
• MDR Text Key: 15271085
• Report Number: 8010047-2014-00094
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2014

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 Catalogue Number: BML-V232QR-30
• Device Lot Number: K3Z03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR