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

Model Number FG-V425PR

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus for evaluation.So olympus could not confirm the reported phenomenon.From the manufacturing history of the same lot of the subject device, nothing abnormal was detected in the following items possibly contributing to the reported event.Appearance of the device.Rotate function of the basket.Opening/ closing force of the basket.Shape of the basket.Based upon the similar cases in the past, omsc considers that the incarceration might occur because the calculus could not go through the bile duct under the following conditions.The calculus was larger than the papillary orifice.The bile duct was narrow.A large number of calculi were grasped at a time.The basket was deformed while repeatedly retrieving the calculus.In addition, the instruction manual of this device calls for attention as bellow.Check that no abnormality is detected in the action of the handle.If there is any abnormality, the calculus may not be retrieved and/or the basket with calculus engaged may not be removed from the body.When the basket does not open and/or close smoothly, do not apply force but move the forceps elevator, set the scope's angle back, or move the position of the basket until the basket opens and closes smoothly.If the action is forced, the tube may stretch and the resistance of the handle may increase.Also the calculus may not be retrieved, and/or 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.

Event Description

The procedure in the event was an ebd for the common bile duct bearing calculus.When the physician used the subject device attempting to retrieve the calculus prior to placing the drainage tube, but it was incarcerated.When the physician used a mechanical lithotripter, (b)(4), to solve the incarceration, the calculus was released from the grasper (basket) and the incarceration was solved.After that, the physician did not perform the retrieval of the calculus, completing the procedure with placing the drainage tube.There was no patient injury reported.The physician continues follow-up of the patient and has not determine a treatment policy.Additionally, there has been no malfunction reported about (b)(4).

• Brand Name: SINGLE USE RETRIEVAL BASKET V
• Type of Device: SINGLE USE RETRIEVAL BASKET V
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 6028859
• MDR Text Key: 57402409
• Report Number: 8010047-2016-01339
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FG-V425PR
• Device Lot Number: 66K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• 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