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

Model Number URF-P6R

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to service for evaluation.The evaluation confirmed the reported "the doctor burned the tip of the scope when using a laser".A visual inspection was performed and a burn mark was found on the distal end body at the channel opening.The burn at the tip was produced by a laser as stated in the complaint.In addition, the bending section skeleton was fond protruding through the bending section cover approximately 70 mm from the distal end with metal exposed causing a leak.The bending section cover was removed in order to verify the extent of the bending section damage.The bending section skeleton was fully separated producing sharp edge near the insertion tube side.The bending section support pins are still intact and not lifting.Further findings include: a failed leak test at the seam of the distal end body, a dent on the insertion tube, broken fibers scattered throughout the image, and a collapsed biopsy channel.The damage is located in the same vicinity as the broken bending section skeleton.The lead biomedical engineer at the user facility further reported the broken bending section was observed during reprocessing.The facility has received the ¿instructions for safe use¿ manual and performed the inspections according to the manual.A leak test was performed prior to procedure.Based on the evaluation, the cause of the bending section skeleton breaking is potentially due to excessive stress or impact to the bending section.The instruction manual states the following; ¿do not twist or bend the bending section with your hands.Equipment damage may result¿.Additionally, the instructions for safe use manual indicate that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment.

Event Description

The manufacturer was informed that during the middle of a procedure, the doctor burned the tip of the scope while using a laser.There was no issue withdrawing the scope from the patient.There was no delay and outcome of the procedure was good as the procedure was completed using another scope.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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8848744
• MDR Text Key: 203152391
• Report Number: 8010047-2019-02774
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2019
• 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