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

Model Number BML-V242QR-30

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 05/26/2014

Event Type  Injury  

Manufacturer Narrative

The coil sheath was returned to omsc for investigation.However, we couldn't confirm the basket wire since it was not returned.The investigation confirmed that there were multiple deformations on the coil sheath.According to the investigation, omsc considers that the calculus was too hard to crush and it caused this event.The device instruction manual has warned users that there is possibility the calculus cannot be crushed by lithotriptor, and it is also describes what to do if the lithotriptor cannot crush the calculus.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus medical system corp.(omsc) was informed that during crushing calculus with the lithotripter in the common bile duct, the doctor couldn't' crush it.He couldn't withdraw calculus and the device from the patient.The facility cut the insertion portion of the device and removed the sheath and used emergency handle.However, they apprehended perforation of the common bile duct and decided to perform open surgery.

• 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, toyko 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: 4006322
• MDR Text Key: 15953294
• Report Number: 8010047-2014-00433
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BML-V242QR-30
• Device Catalogue Number: BML-V242QR-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR