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

Model Number BML-V442QR-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

Olympus med systems corp (omsc) was informed that during endoscopic retrograde cholangiopancreatography (ercp), the doctor inserted the device into the bile duct and captured the stone after the staff nurse set up the device and carried out the relevant tests to make sure it was connected properly.However, he couldn't crush it.They removed the product but the basket had dislodged from the sheath and was stuck inside the pt.The doctor did not want to remove the scope so could not use the emergency handle.They went back down with the original sheath and the basket somehow re-attached to the sheath.The stone had only been broken slightly and due to the distress of the pt they had to place a stent and abandoned the procedure.Pt was distressed during procedure but is fine.

Manufacturer Narrative

The subject device has 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 info becomes available at a later time.This report is being submitted as a med 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
• MDR Report Key: 4250434
• MDR Text Key: 5050580
• Report Number: 8010047-2014-00673
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BML-V442QR-30
• Device Lot Number: 3YK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1