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

Model Number CYF-VHR

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer contacted olympus to report a device malfunction observed during reprocessing.There was a wire sticking out of the insertion unit.There was no report of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the evaluation and legal manufacturer investigation.The device was returned to the service center for evaluation.Cuts were noted on the insertion tube causing a leak to be observed.Minor scratches were noted on the scope¿s plastic cover and light guide lens.There were white dots noted in the scope¿s image.The scope¿s id chip showed 817 total uses.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.As a result of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.The date of manufacture is december 9, 2016 and about 4 years and 2 months have passed.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: there is a possibility that the bending tube was damaged and metal protruded because some external force was applied to the bending section.The legal manufacturer confirmation of contents described in the instruction manual> cyf-vh/vhr/vha operation manual chapter 3 preparation and inspection 3.3 inspection of the endoscope.Inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Holding the control section with one hand, carefully run your other hand back and forth over the entire length of the insertion section.Confirm that no objects or metallic wire protrude from the insertion section.Also, confirm that the insertion tube is not abnormally rigid.Using both hands, bend the insertion tube of the endoscope into a semicircle.Then, moving your hands as shown by the arrows in figure 3.4, confirm that the entire insertion tube can be smoothly bent to form a semicircle and that the insertion tube is pliable.Gently hold the vicinity of the distal end and a point 10 cm from the distal end.Push and pull gently to confirm that the junction between the bending section and the insertion tube is not loose.The device was returned to the service center for evaluation.Cuts were noted on the insertion tube causing a leak to be observed.Minor scratches were noted on the scope¿s plastic cover and light guide lens.There were white dots noted in the scope¿s image.The scope¿s id chip showed 817 total uses.

• Brand Name: 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: 11516902
• MDR Text Key: 244803564
• Report Number: 8010047-2021-03926
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411298
• UDI-Public: 04953170411298
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1