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

Model Number URF-V2

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation confirmed the complaint for broken tip.The evaluation found a tear in the bending section cover at the base of the bending section, which exposed the metal skeleton.The bending section skeleton was also broken at this location, as well as in the middle of the bending section.There were no sharp edges found at either broken skeleton location.A potential cause for the damage is mishandling.A review of service history found no olympus repairs or service since 2016.To mitigate against scope damage and patient injury, both the scope operation manual and instructions for safe use documents contains several warning statements regarding inspection and operation.The instructions for safe use states ¿visually inspect the bending section for no metallic parts protruding from the bending section¿ prior to the procedure, and includes photos for reference.The operation manual likewise states that prior to scope use, ¿inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ and ¿gently hold the vicinity of the distal end and at the point 10 cm from the distal end.Push and pull gently to confirm that the junction between the bending section and the insertion tube is not loose and that no irregularities are observed on the bending section.¿ the operation manual also includes functional pre-procedure test of the bending mechanism, and states, ¿if the movement of the up/down angulation lock and the angulation control lever is loose and/or not smooth, or the bending section does not angulate smoothly, the bending mechanism may be abnormal.In this case, do not use the endoscope because it may be impossible to straighten the bending section during an examination, and patient injury, bleeding, and/or perforation may result.¿ the procedure was completed with another scope, per the operation manual recommendation to ¿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 unknown procedure, the clinician noticed that the scope would not angulate, and removed it from the patient.Damage was seen on the distal end cover about 3 inches from the tip.There were no sharp edges noted.There was no reported patient injury or device fragment fallen into the patient.The procedure was completed with another scope.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 8053077
• MDR Text Key: 129040850
• Report Number: 2951238-2018-00692
• Device Sequence Number: 1
• Product Code: FGB
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Device Catalogue Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2018
• 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