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

Model Number BML-V242QR-30

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/15/2014

Event Type  Injury  

Event Description

Olympus medical system corp.(omsc) was informed that during crushing biliary stone, the basket caught the stone regularly but the metal sheath near handle buckled and the metal pipe broke abruptly.The doctor abandoned the procedure and performed open surgery to remove the basket from the patient.The patient was discharged after standard postoperative observation period.According to a report, the patient is fine.

Manufacturer Narrative

The subject devices have not been returned to omsc for investigation.The exact cause of the user's experience could not be conclusively determined.A supplemental report will be submitted, if additional and significant information becomes available at a later time.This 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 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi 192-8-507 ; JA 192-8507
• MDR Report Key: 4196350
• MDR Text Key: 4962502
• Report Number: 8010047-2014-00552
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: BML-V242QR-30
• Device Lot Number: 42K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2014
• 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: 61 YR