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

Model Number CYF-V2

Device Problems Mechanical Problem (1384); Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, multiple follow up attempts were made via telephone and in writing to contact the user facility to obtain addition information regarding the patient, procedure and scope but no information has been obtained to date.The scope was returned to olympus but the evaluation is in progress.Olympus will continue to investigate the reported event.If additional information becomes available, this report will be updated accordingly.

Event Description

Olympus was informed that during a procedure, a scope became stuck inside the patient¿s urethra.The scope¿s insertion tube was in a 360 degree loop and the up lever worked but the down lever did not move the bending section tip of the scope.The physician had decided to cut the scope¿s insertion tube and had to rush the patient into 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 to provide the initial device evaluation results for the reference scope.A visual inspection was performed and found the scope is broken / cut in half at the middle section of the insertion tube.The internal elements were exposed and the metal coil sheath inside the insertion tube is severely stretched and broken apart.Additionally, the metal coil sheath has a sharp surface at the broken site.The condition of the insertion tube confirms the initial report that the scope was cut in half by the physician.The bending section portion at the distal area of the scope has a severe bend/kink and the bending section cover is stretched.A review of the scope¿s instrument history records indicates the scope was purchased on december 17, 2014 and was last repaired on november 7, 2017.Olympus will continue to investigate.The scope will be sent to the oem for further investigation.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report is being submitted to provide results of device evaluation by the oem and result of the oem's record review.The device history record (dhr) was reviewed and no anomalies during the manufacturing process were noted.The device evaluation identified a kinked passive bending section, deformed skeleton rings and kinked a-coil ("d" side).The damage to the insertion section and the looped insertion section was deemed likely due to scope handling other than during the procedure.The scope's instructions for use (ifu) manual provides statements directing the user to inspect the scope prior to use: inspect the external surface of the entire insertion tube for dents, bulges, swelling, peeling or other irregularities.Holding the insertion tube gently with one hand, carefully run your fingertips over the entire length of the insertion tube in both directions.Inspect for any protruding objects or other irregularities.Also confirm that the insertion tube is not abnormally rigid.Inspection of the bending mechanism: if the movement of the up/down angulation lock and the angulation control lever are not smooth, the bending mechanism may be abnormal.In this case, do not use the endoscope because it may be impossible to straighten the bending section during an examination.

• 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: 8324293
• MDR Text Key: 135678199
• Report Number: 2951238-2019-00429
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170287091
• UDI-Public: 04953170287091
• 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: 01/24/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 02/20/2019; 02/12/2019; 04/12/2019
• Supplement Dates FDA Received: 03/08/2019; 03/11/2019; 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention