MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2022

Event Type  Injury  

Event Description

The customer reported during a diagnostic flexible cystoscopy procedure, small black device fragments fell off the cysto-nephro videoscope into the patient's bladder.Additional intervention with multiple different graspers and frequent bladder washouts were required in order to retrieve the foreign material.The device malfunction caused an unspecified delay in the procedure.It was reported there are plans for a future procedure to verify if device fragments were retained or voided out.Additional details have been requested and are in progress.

Manufacturer Narrative

The device referenced in this report has been evaluated by olympus and the customer's allegation was confirmed.Preliminary findings are reported.The investigation is ongoing.Physical evaluation of the suspect device revealed the following: the biopsy channel is leaking.Distal end insulation test has failed due to detached adhesive.Bending section cover adhesive is detached, chipped, cracked, or has a burr.Cable tube is buckled or wrinkled.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the bending section cover (a-rubber) adhesive was damaged by the user¿s handling for a long time.Since the user used the device in this condition during the procedure; the adhesive fell off in the patient¿s bladder.As a result, the procedure time was extended to collect the fragments from the patient¿s bladder.However, the root cause of this reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿¿¿preparation and inspection - 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.¿.¿important information ¿ please read before use - warnings and cautions - do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.¿.This supplemental report includes information added to b5.Olympus will continue to monitor field performance for this device.

Event Description

Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; fukushima, nishishirakawa-gun 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15298340
• MDR Text Key: 298668758
• Report Number: 3002808148-2022-01407
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other