MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2R

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  Injury  

Event Description

The customer reports during a diagnostic cystoscopy using a viscera cysto-nephro videoscope to assess response to therapy for bladder cancer, the scope was unable to pass through a stricture at the bladder neck.Sequence of events as follows: an olympus flexible scope was connected and white balanced in a routine fashion.The scope was well lubricated and subsequently the patient's urethral meatus was cannulated.The patient had a normal-appearing urethra with no masses, lesions, or polyps.The prostate was absent.There were no masses lesions polyps or areas suspicious for cancer.Neobladder without evidence of tumor.Pt had a 14-fr stricture near the bladder neck.The scope was unable to pass through the stricture.Upon retracting, the scope broke and appeared to loop de loop on itself.As such, it was unable to be retracted and removed.The patient was taken urgently to the operating room for removal.The patient's current condition is stable.The customer states there were no procedural or anatomical challenges that could have caused or contributed to the reported event.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 14928184
• MDR Text Key: 295312851
• Report Number: 2951238-2022-00454
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339523
• UDI-Public: 04953170339523
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/07/2022,07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 92 KG