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

Model Number FG-V425PR

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the delivery date, it was found no irregularities.Based on the past similar cases, it was known that subject device could not be removed due to the state of the calculus.Also, the intended use of the subject device is to retrieve biliary calculus but the subject device was used to retrieve and to crush pancreatic calculus in this event.Therefore, the operation beyond the intended use of the subject device may be the cause of the event.The above device handling has been warned in the instruction manual as follows; a) 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.Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case this instrument with calculus engaged may not be removed from the body, or in case the calculus cannot be crushed even the lithotriptor bml-110a-1 is used in combination.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.

Event Description

During removal of biliary and pancreatic calculus, the subject device was used.The user tried to retrieve the pancreatic calculus with the subject device, but the subject device could not be removed from the pancreatic duct (it was incarcerated).When the incarceration was managed using an emergency lithotriptor, the basket wire of the subject device broke.The surgeon performed an unspecified treatment to remove the device and completed the retrieval of the calculus.The patient's prognosis was reported to be good.This is the report regarding the incarceration of pancreatic calculus.

• Brand Name: SINGLE USE RETRIEVAL 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8914090
• MDR Text Key: 213240804
• Report Number: 8010047-2019-02977
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-V425PR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2019
• 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