MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE RETRIEVAL NITINOL BASKET V; SINGLE USE RETRIEVAL BASKET

Model Number	FG-V451P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The olympus endoscopy account manager (eam) conferenced the olympus technical support engineer (tse) and the customer contact who was in the procedure during the call.The customer reported that the lithocrush wire basket broke (no specific model or lot number was provided).The customer reported they were attaching the emergency handle and that is when the wire broke.The patient was sent to the surgery to have the broken piece retrieved.To date, the patient was reportedly doing well.The customer later confirmed the basket broke at the end of the therapeutic procedure.There were no other devices involved.The intended procedure to extract stones, an endoscopic retrograde cholangiopancreatography (ercp), was not completed as planned.An open abdominal emergency surgery was required to retrieve the basket and stones that fell inside the patient's common bile duct.The basket and stones were successfully retrieved and there were no further complications.The customer also reported the patient had a significantly contracted gallbladder with necrosis, on the distal half (encompassing the infundibulum), which posed a challenged to the procedure being performed.The mfr medwatch report associated with this event was submitted on time under manufacturer report # 8010047 - 2021 - 09528.Upon review olympus is submitting the corresponding importer medwatch report.

• Brand Name: SINGLE USE RETRIEVAL NITINOL BASKET V
• Common Device Name: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 17035019
• Report Number: 2429304-2023-00168
• Device Sequence Number: 15067671
• Product Code: LQR
• UDI-Device Identifier: 04953170395321
• UDI-Public: 04953170395321
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/31/2023
• Report Date (Section F): 07/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: FG-V451P
• Device Lot Number: 08K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL FG-V451P STERILE LOT 0K6125
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White