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

Model Number BML-V442QR-30

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/17/2022

Event Type  Injury  

Event Description

The customer called olympus technical support to report, during a bile duct stone removal procedure using a single use mechanical lithotriptor v, while trying to remove a stone from the bile duct, an attempt was made to crush the stone and the device broke.The customer did not have an emergency handle.The physician was able to remove the scope from the patient, but the endotherapy device (lithotriptor) remained inside the patient.The customer did have the instruction manual readily available and olympus technical support referred the customer to the pages for emergency treatment.During further discussion, the customer indicated the device could not be safely removed from the patient and the patient possible had to be taken for an open surgical procedure to remove the trapped device.The phone call abruptly ended after this information was provided.Three attempts were made at that time to call the customer back with no answer.Additional information has been requested regarding the reported event.At this time, no additional information has been provided.

• 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
• MDR Report Key: 14684457
• MDR Text Key: 294498156
• Report Number: 2951238-2022-00426
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2022,06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V442QR-30
• Device Lot Number: 19V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED SCOPE
• Patient Outcome(s): Required Intervention; Other