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

Model Number CYF-V2

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

The scope was returned to olympus for evaluation.The evaluation found the distal end cover insulation in critical condition.The distal end cover was found cracked and burned.The bending section rubber glue was found cracked.In addition, the insertion tube was found with minor scratches, buckles, and dents.The light guide tube and the video cable were also found with minor scratches.The scope was serviced and returned to the user facility.Based on the investigation findings, the exact cause of the reported event could not be conclusively determined; however, improper maintenance of the scope could not be ruled out as a contributing factor to the reported event.The instruction manual provides warning and caution statements in an effort to prevent equipment damage and patient harm.¿the probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase.In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each facility should inspect the items specified in this manual periodically.Before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.If this instrument malfunctions, do not use it.Return it to olympus for repair.Anytime you observe an irregularity in an endoscope function, stop the examination immediately and slowly remove the endoscope while viewing the endoscopic image if possible.Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.¿.

Event Description

Olympus was informed that during a cystoscopy procedure with urethral dilation, the scope became stuck inside the patient¿s bladder upon removing the scope from the patient.Surgery was performed to remove the scope from the patient¿s bladder and a different scope was used to complete the intended cystoscopy procedure.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.On november 9, 2018, olympus received additional information regarding the reported event, which alleges the endoscope caused severe and permanent injuries.It was reported that upon insertion of the scope, it collapsed and coiled inside the patient¿s urethra and could not be extracted without surgical intervention.The patient was rushed into emergency for surgery wherein general anesthesia was administered.The scope was successfully removed from the patient after the surgical intervention.It was further reported that the patient experienced extreme discomfort and suffered nerve damage as a result of the surgery.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from nwb to faj and 510(k) number.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the oem.A review of the dhr records was conducted for the subject scope and found no anomalies during the assembly process.In addition, a review of the instrument history records shows the scope was purchased on march 14, 2011 and was last repaired on june 30, 2017.

• 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
• MDR Report Key: 7356190
• MDR Text Key: 102997977
• Report Number: 2951238-2018-00194
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/29/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Device Catalogue Number: CYF-V2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 11/09/2018; 02/13/2019; 04/02/2019
• Supplement Dates FDA Received: 12/05/2018; 03/02/2019; 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 67 YR