MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS VORTICCATCHV; DISLODGER, STONE, BILIARY

Model Number OK6125

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Abdominal Pain (1685); Erosion (1750); Inflammation (1932); Necrosis (1971); Jaundice (2187)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Olympus 8 wire basket inserted into bile duct, not able to pull large stone out, put lithotripsy handle on basket but wire near handle broke, wire snapped.Insert egd scope to inspect ampulla which appeared to have no severe trauma.Grasped wire and gently tried to move it back and forth in order to attempt to free the basket but were not successful.Patient required surgery for removal of basket and t tube placement.Findings at operation: at exploration, he was found to have subacute calculous cholecystitis with a significantly contracted gallbladder that had necrosis on the distal half encompassing the infundibulum.The gallstone was approximately 15 mm in greatest dimension and had completely eroded through the infundibulum into the common hepatic duct.There was, effectively, no cystic duct that remained.The basket device was impacted within the distal common bile duct at the papilla of vater.No other common hepatic nor common bile duct debris remained.No other significant pathology was appreciated.Pt is a (b)(6) y/o male who presented to the er with complaints of yellowing of his skin that has gotten worse over the last several days.He also reports abdominal pain that is right upper quadrant in nature.He denies any weight loss.Bowel movements are normal.

• Brand Name: OLYMPUS VORTICCATCHV
• Type of Device: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 12353688
• MDR Text Key: 267888884
• Report Number: MW5103384
• Device Sequence Number: 1
• Product Code: LQR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: OK6125
• Device Lot Number: 08K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 70