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

Model Number BML-V442QR-30

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be confirmed at this time.As part of our investigation, olympus made multiple followups by telephone and in writing in an attempt to gather additional information on the reported event.However no additional information was obtained.A potential cause is user technique.The device was being threaded through the common bile duct at the time of breakage, along with a guide wire inserted into the tip.The instructions for use contain specific directions to insert the device with distal tip parallel with the guide wire, and to not forcibly insert the device with a sharp angle between the distal tip and the guide wire, which can damage the distal tip.The instructions for use also contain directions for preventive measures, including pre-procedure exercise of basket opening and closing, visual inspection for anomalies, and having a spare device available during procedures.

Event Description

During an ercp (endoscopic retrograde cholangio-pancreatography) procedure to remove a common bile duct stone, the distal tip broke off of the basket of an olympus single use mechanical lithotriptor v, while inside the patient.The wire-guided tip broke off while the physician was trying to slide the device into the duct.A boston extraction balloon was used to extract the original target tissue and the fallen off device tip, and to complete the ercp procedure.There was no reported patient injury.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6952976
• MDR Text Key: 90415523
• Report Number: 2951238-2017-00681
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/16/2017

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: 73K
• Other Device ID Number: 04953170218422
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/16/2017
• 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