MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE RETRIEVAL NITINOL BASKET V; SINGLE USE RETRIEVAL BASKET

Model Number FG-V451P

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an unspecified procedure, the subject device was used.In the procedure, the user tried to retrieve the calculus with the subject device, but the subject device could not be removed.Then, the surgeon operated the subject device and tried to crush the calculus, but, canceled the operation due to an extraordinary noise.The intended procedure was completed with an electronichydraulic lithotripsy through the choledochoscope.There was no patient injury reported.This is the report regarding the failure of the removal of the subject device.

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Two basket wires around the distal end were broken off.The broken surface of the basket wires showed that it was subject a large load.There was no abnormality in the diameter of the basket wires.The operation rod was broken off near the handle.The broken section of the rod shaped like a large load applied.There was no abnormality in the diameter of the operation rod.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc assumes that the subject device could not be removed due to the state of the calculus.Also, it was known that the basket wires and the operation rod were broken off due to adding an excessive load to the basket wires and the operation rod.The above device handling has warned in the instruction manual as follows.Do not use this instrument for a calculus that is assumed impossible to be retrieved by this instrument in preoperative diagnosis, intraoperative contrast enhancing or after papillotomy/papillary dilation.Do not use this instrument when it is inevitable to grasp many calculus at a time.The basket with calculus engaged may not be removed from the body.This instrument will deform and/or deteriorate by performing calculus retrieval.Repetition of calculus retrieval will extend the effect.By such deformation and/or deterioration, calculus may not be retrieved and/or the basket with calculus engaged may not be removed from the body.If calculus retrieval needs to be repeated in a single case, make sure to check the action and the appearance each time that no abnormality is detected (e.G., basket wire cut or worn, tube sheath bent etc.).Stop use when any abnormality is detected.

• Brand Name: SINGLE USE RETRIEVAL NITINOL BASKET V
• Type of Device: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9248697
• MDR Text Key: 219202775
• Report Number: 8010047-2019-03748
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• PMA/PMN Number: K170811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FG-V451P
• Device Lot Number: 94K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1