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

Model Number URF-P6R

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and found channel leak and stain on image from device.The channel leak is noted to have been caused by a tear.

Event Description

It was reported to olympus that there was air/water leakages or fluid invasion and the device failed the leak test.It was also noted that a broken wire caused the device to remained angulated causing the end to come apart and be immobilized.

Manufacturer Narrative

This supplemental report was submitted to provide new information from the oem's (omsc) investigation.The oem conducted the investigation of the angulation becomes locked-cannot disengage based on the service/repair event.Additionally, a review of the device history record (dhr) confirmed the subject scope was shipped in accordance with specifications via dhr.A review of the repair history confirmed the scope previously serviced via repair on (b)(6) 2020.An investigation was completed by the oem and determined that there was no manufacturing, material or processing related cause for this failure mode.The noted bending rubber was broken/torn/ruptured with metal protruding is a known issue and has previously been investigated.A design change was completed in order to improve safety to the patient.The oem determined the likely cause of the reported event can occur a.The angulation wire was stuck by sliding coil pipe.Coil pipe may have slid by angulation while bending section has been contacted with patient body.B.The angulation wire got stuck from corrosion inside the coil pipe.Coil pipe and angulation wire may have been corroded from leakage which occurred at the biopsy channel.Ifu states the followings to detect the event.In this case, there may have been a deviation from the followings in instructions for user (ifu) for there was no report on angulation abnormality from the user.3.3 inspection of the endoscope : operate the up/down angulation control lever slowly in each direction until it stops.Confirm that the bending section angulates smoothly and correctly and that maximum angulation can be achieved.Ifu states the followings on handling to prevent the event.In this case, there may have been deviation from the followings in ifu.Reprocessing manual: 1.4 precautions : perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause damage to the bending mechanism or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.

• 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
• MDR Report Key: 10125471
• MDR Text Key: 209394274
• Report Number: 8010047-2020-03160
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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: 05/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1