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

Model Number FG-V435P

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  Injury  

Event Description

It was reported that the single use retrieval basket became incarcerated in the bile duct while attempting to remove a previously implanted single use biliary drainage stent during an endoscopic retrograde cholangiopancreatography and stent replacement procedure.The stent also could not be removed from the basket.A mechanical lithotripter was then used to remove the basket and break the stent.It was also reported that the stent, which was scheduled to be replaced, appeared to have strayed and that it ruptured and became incarcerated during removal attempts of the basket.Some of the pieces were torn off and retrieved but some remained inside the patient.There were no reports of further patient harm.

Manufacturer Narrative

This report is related to the following linked patient identifier: (b)(6).The subject device was not returned to olympus for evaluation, as the device was discarded by the user facility.The investigation is ongoing, and this report will be supplemented when new and relevant information becomes available later.

Event Description

It was reported, the patient underwent laparotomy, and the plastic stent was removed.

Manufacturer Narrative

This report is being supplemented to provide additional information from the customer.Please see updates to b5 and h6.

• Brand Name: SINGLE USE RETRIEVAL BASKET V
• Type of Device: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18790417
• MDR Text Key: 336377642
• Report Number: 9614641-2024-00490
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-V435P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• 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
• Treatment: PBD-V631P/UNKNOWN SIZE AND LOT NO.
• Patient Outcome(s): Required Intervention