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

Model Number CYF-VH

Device Problem Entrapment of Device (1212)

Patient Problem Injury (2348)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

The scope was not returned to the service center for evaluation.The cause of the reported event cannot be determined at this time.An investigation to obtain more detailed information regarding the reported events is ongoing.

Event Description

The service center was informed that during an unspecified procedure the scope became stuck in the patient.The patient was taken to the operating room and underwent surgery to remove the scope.The patient is reportedly doing well.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.The scope was received with the insertion tube cut.The original equipment manufacturer performed a visual inspection of the received device and noted that the scope was stuck in two areas.The bending tube was stuck in the ¿up¿ position and the passive bending section was bent sharply toward up side.The skeleton ring was found deformed in the bending tube, the a-rubber was found incised at the passive bending section.The metal braid was found protruding.Bending section (down side): the a-wire was found untensioned.No deformation was found in the bending tube.Bending section (up side): confirmed the a-wire tensioned.String guide got deformed due to the deformed bending tube causing the a-wire to become stuck.In the passive bending section, the metal braid mesh (down side) was found shifting to the control body side, then a gap was found generating.A flex was found protruding from this gap.String was found frayed due to edge of the braid which shifted to the control body side.This string was found protruding from the a-rubber.Bending section stuck: this event was likely caused by the a-wire stuck becoming stuck during the patient procedure as a result of the deformed string guide.The deformed string guide was likely caused by the deformed skeleton ring.Most likely, the skeleton ring was deformed before the patient procedure, as the procedure would not put stress on the bending section.Passive bending section stuck: this event was caused by the flex stopped returning to the original position due to exposed braid.The cause of non-smooth insertion cannot be determined.However, impossibility to straighten the bending tube and passive bending section due to skeleton ring malfunction which had occurred before insertion can be presumed as a probable cause.The oem reported that this event could be detected by performing the inspection before use, as the appearance becomes significantly changed when malfunction occurs.Moreover, it is likely a large stress was applied to the passive bending section from the fact that the flex shifted to the rear end.This stress was unlikely to occur during a patient procedure.Stress applied to the insertion tube during the additional surgery to remove the indwelling portion of the scope is a probable cause.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results, and provide additional information from the user facility.Additional information received from the user facility states that the scope was not in the kidney, unable to advance through the bladder neck.The details of the direction of the locked distal end is unknown.Before the bending section locked, there was no noise noted by the nursing staff.The scope required to be cut in order to be removed from the patient using a ring cutter, pin cutter and scissors.This was one location cut on the scope.These tools were used to cut and remove the insertion tube from the distal end.The scope was not able to be removed in the procedure area following being cut.The customer was not using any other accessories during the procedure when this malfunction occurred.There was no trouble with endoscope's image noted by the nursing staff.Regarding the leak test, checked by medical device reprocessing before cleaning, not before procedure.Urologists may test prior to starting.This cyf-vh has been used 53 times before this malfunction occurred with this device.Due to the biohazard status of the device at the olympus canada location.The device was not returned to the service center for evaluation.The device was visually inspected by olympus quality and regulatory personnel as well as the manufacturer¿ s engineer using a web cam.The scope was cut into two parts (insertion part and control section).The insertion part was observed and the bending section from distal end was angled and locked.The bending section was noted to be buckled approximately 7cm from distal end.It could be straighten when pulling the distal end by finger but it returned once finger released.There were some of small dents were found on insertion tube but not so critical.The control section was inspected and found the engage lever position was in the free positon.The angle lever could be moved smoothly, without no restriction.Due to the condition of the scope the root cause cannot be determined at this time.The findings of the visual inspection will be shared with the original equipment manufacturer (oem) for further investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return date.

• 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: 8875182
• MDR Text Key: 153712537
• Report Number: 8010047-2019-02907
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention