MAUDE Adverse Event Report: OLYMPUS MED SYSTEMS CORP SINGLE USE MECHANICAL LITHOTRIPTOR

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2014

Event Type  malfunction  

Event Description

Olympus was informed that the basket wires at the distal end of the lithotriptor broke while crushing a large and hard stone in the pancreatic duct.The physician pulled the lithotriptor to remove the rest of basket from the pt.There was a moderate amount of bleeding, and the pt's oxygen saturation dropped considerably.The endoscope had to be removed from the pt, and a non-rebreather mask was applied with a jaw thrust after obtaining a proper saturation the endoscope was re-inserted and a biliary stent was inserted in the pancreatic duct.The procedure was aborted, and the pt was taken to the recovery room for observation.The pt was kept longer in the recovery room, and was discharged after unspecified time.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for eval.The exact cause of the user's experience could not be conclusively determined.If additional info becomes available at a later time, this report will be supplemented.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR
• Type of Device: LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MED SYSTEMS CORP; 2951 ishikawa-cho; hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MED SYSTEM CORP; 2951 ishikawa-cho, hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: laura storms ; 2400 ringwood ave.; san jose, CA 95131 ; 4848965688
• MDR Report Key: 3811133
• MDR Text Key: 4386277
• Report Number: 2951238-2014-00135
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V442QR-30
• Device Catalogue Number: BML-V442QR-30
• Device Lot Number: 36K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention