MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The customer¿s reported angulation issue was confirmed.A visual inspection was performed on the returned device and found critical defects to the scope¿s distal end cover, bending section glue, bending section and light/image bundle.The angulation function of the scope was found to be abnormal.Further evaluation noted restrictions when attempting to insert test instruments into the scope¿s forcep and brush passage.The device has been repaired and returned to the customer.As a preventive measure, the scope operation manual has pre-procedure instructions for inspecting the scope, including inspecting the bending section for deformation, and functional verification of the angulation.The operation manual states that during the procedure, if the angulation malfunctions, ¿stop the procedure immediately and place the up/down angulation lock in the free ¿f ¿ position.Then carefully withdraw the endoscope while observing the endoscopic image.If the endoscope cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it.Rather, withdraw the endoscope carefully.If the endoscope cannot be withdrawn from the patient, consider removing it through open surgery and take proper measures.¿ and ¿do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.¿ the operation manual also recommends ¿be sure to prepare another endoscope to avoid interruption of the examination due to equipment failure or malfunction.¿.

Event Description

Olympus was informed that during an unspecified procedure, the scope was inserted into the patient¿s kidney and while inside the calyceal diverticulum the scope angulated backwards.The surgeon reported that the scope was bent 360 degrees and appeared in its own endoscopic view.It took approximately 10 minutes of maneuvering to straighten out the scope so it could be safely removed.It is unknown if the intended procedure was completed.There was no patient injury reported.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8200653
• MDR Text Key: 131772665
• Report Number: 2951238-2018-00813
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1