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

Model Number URF-P5

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.The evaluation found a hole on the bending section cover and the hole measured at approximately 2mm in size.The scope failed the leak test, likely due to the hole in the bending section.In addition, the scope showed evidence of non olympus parts found within the distal end, bending section glue, insertion tube, control body, and eyepiece of the scope.Based on the investigation findings, the root cause of the reported event is most likely due to improper maintenance of the scope.The scope was serviced and returned to the user facility.The instruction manual states, prohibition of improper repair and modification.This instrument does not contain any user-serviceable parts.Do not disassemble, modify or attempt to repair it; patient or operator injury and/or equipment damage can result.Equipment which has been disassembled repaired, altered, changed or modified by persons other than olympus own authorized service personnel is excluded from olympus limited warranty and is not warranted by olympus in any manner." as part of our investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to assess and observe the facilities reprocessing practices.The user facility has declined the ess visit.

Event Description

Olympus was informed that towards the end of a cystoscopy with stent placement procedure, a black foreign object fell inside the patient.The foreign object was retrieved.In addition, a fluoroscopy was performed and the patient was irrigated.The procedure was completed using a different scope.No patient injury.Olympus was further informed that the scope was inspected prior to use and the scope is manually cleaned and disinfected using steris valsure enzymatic cleaner.The user facility also utilizes an olympus leak tester (mu-1).The scope is stored in a sterile container.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fbn to fgb.

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6097869
• MDR Text Key: 59872138
• Report Number: 2951238-2016-00858
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Device Catalogue Number: URF-P5
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• 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
• Treatment: STERIS VALSURE ENZYMATIC CLEANER