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

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2021

Event Type  Injury  

Event Description

The physician reported to the olympus clinical sales specialist, there were multiple olympus device malfunctions during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) performed (b)(6) 2021 and the procedure took four (4) hours long to complete.The physician first attempted the ercp on (b)(6) 2021 but he was unable to get the lithocrush wire around the large stone, approximately 2.2cm stone, and did not want to proceed without his primary support team available for the procedure.The first procedure was uneventful and the olympus device did not malfunction.The patient was kept in the hospital due to elevated laboratory results and the second procedure was planned for the following week.During the second ercp procedure, the physician used an olympus endoscope and inserted the lithocrush basket around the 2.2cm stone and tried to remove the stone with seven (7) different extraction balloons (single-use olympus multi-3v extraction balloons, model and lot number unknown).The physician stated the extraction balloons broke because the stone edges were jagged.The physician then used the lithocrush basket.He proceeded to put the lithocrush basket around the stone and as the seasoned technician withdrawals the wire to crank it down, the lithocrush basket breaks at the ratchet handle.Then, the emergency handle was used, as indicated.The endoscope was removed, a metal sheath was inserted and connect to the emergency handle.As force was being applied to the basket to remove the stone, the wire broke again.There was enough wire viable for another attempt with the emergency handle and the basket broke a 3rd time.At that time, the wire is too short and the emergency handle could no longer be used.The physician proceeded to use a non-olympus laser to lase the stone.However, the first non-olympus laser device was at the end of life and a 2nd device had to be used to lase the stone.Using a non-olympus controlled radial expansion balloon (6x12mm) with biopsy forceps, the basket was retrieved and no foreign material was left behind; this was confirmed by x-ray.A non-olympus 10x6 fully covered metal stent was implanted due to a stone fragment remaining.There was an unknown procedural delay due to the multiple malfunctions.The patient was admitted to the hospital for 24 hour observation and sent home.The patient did not have any post-operative complications.On (b)(6) 2021, the physician¿s partner performed the third ercp with an unknown balloon and basket (not olympus) with further incident.This event includes 1 report for patient identifier (b)(6) for the lithocrush basket.

• 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: 13008120
• MDR Text Key: 282269608
• Report Number: 2951238-2021-00456
• 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: Physician
• Type of Report: Initial
• Report Date: 11/16/2021,12/15/2021

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: 03K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TJF Q189V, 2618548
• Patient Outcome(s): Required Intervention