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

Model Number CYF-V2R

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2022

Event Type  Injury  

Manufacturer Narrative

This event has also reported in the importer (b)(4).The device referenced in this report has been returned to olympus for evaluation/repair.Preliminary findings are reported.The investigation is ongoing.Physical evaluation of the suspect device: the complaint device was received with the cover opened on the control body, and the device already inspected by the service group.Olympus performed a visual inspection on the received condition and noted multiple buckles on the insertion tube, next to the bending section cover glue.The bending section cover glue has chemical damage and voids around the edges on both ends.The bending section cover is discolored along with chemical damage.There is also a large cut on the bending section cover, closer to the insertion tube side.The distal end cover has brownish (dried) residue within the opening of the biopsy channel.The objective lens has a non-olympus glue repair surrounding the lens.One side of the non-olympus glue around the objective lens appears to have a small edge forming.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

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.

Manufacturer Narrative

This report is being updated to provide investigation findings.The device history record (dhr) was reviewed and it was confirmed the device met all design and safety specifications when shipped.The instructions for use shipped with the device provides the user with the following information related to reported event: 3.2 inspection of the endoscope 6.Inspect the covering of the bending section for sagging, swelling, cuts, holes, or other irregularities.The definitive cause of the reported event could not be identified.A likely cause would be: (1) manipulation section has corrosion due to liquid invasion through air leak.Angle manipulation disabled due to the corrosion and the distal end of the scope was folded, might have led to the health damage to the patient.The cause of the broken a-rubber could not be identified.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14928191
• MDR Text Key: 295311771
• Report Number: 8010047-2022-11359
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339523
• UDI-Public: 04953170339523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

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?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2014
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 92 KG