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

Model Number CYF-V2

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/31/2018

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.The evaluation of the referenced scope found the bending section cover glue was cracked exposing the threading at the bending section which would indicate that a piece of the bending section cover glue was missing.The bending section cover, distal end plastic cover and insertion tube were intact.The scope did not pass the leak test due to the cracked bending section cover glue at the distal end.There were 385 usages with the device.A review of the scope¿s instrument history record shows the scope was purchased in (b)(4) 2013 and was last repaired on april 20, 2017.The cause of the reported event could not be confirmed, however, the ifu¿s troubleshoot section warns, ¿if any parts of the endoscope fall off inside the patient¿s body due to equipment damage or failure, stop using the endoscope immediately and retrieve the parts in an appropriate way.¿ the instruction manual also provides warning and cautions which state¿ do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, and control section with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.¿.

Event Description

Olympus was informed that after performing a cystoscopy procedure, the doctor saw a small black fragment inside the patient¿s bladder.The scope was then inspected and the doctor noticed a piece of the distal end cover was missing.The small black fragment in patient's bladder could not be retrieved by the staff as they attempted several times.The user facility reported that "because it is small in size the patient will eventually urinate it out.The procedure was completed as the black piece was only noted at the end of the procedure.There was no patient injury reported.In addition, the patient did not require a longer stay or additional treatment.The scope was inspected with no anomalies observed.

Manufacturer Narrative

This report is being supplemented to correct the device product code in d2.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8293453
• MDR Text Key: 135523274
• Report Number: 2951238-2019-00393
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 08/25/2022
• 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: A
• Patient Sequence Number: 1