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

Model Number CYF-V2

Device Problems Particulates (1451); Scratched Material (3020)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The user¿s complaint of black flecks coming out of the scope was confirmed.The device was visually inspected and found the scope has black particles at the distal tip.The scope failed the water dunk test and is leaking from the instrument channel.The channel was verified with proscope and saw multiple tear marks and excessive tear marks near biopsy port.There were chip marks/peeling on the bending section cover glue from the distal end and insertion tube sides.The bending section cover glue has evidence of scratches, which most probably caused the cement to chip off.The peeling off pieces of the bending section cover glue were not returned for evaluation.Also found switch #3 was not working and there was a crack on the video connector.The listed parts were replaced.The device is fully functional and returned to the user facility.

Event Description

The user facility reported that there was an issue with the device.The device had foreign material falling off from the channel.It was like metal coming out of it like little flecks.This event happened during the end of a therapeutic procedure.The procedure was completed with an alternate device.The flecks were very small less than 1mm.The flecks entered the bladder and the patient was allowed to void them out.There was no patient injury or harm.No additional information was provided.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.Updates to sections.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The legal manufacturer determined the likely cause of the reported problem of "foreign material falling off from the channel" as follows: it is inferred, based on the result of the device evaluation and the available information, that the material in the insertion section tube penetrated because the forceps channel was perforated by a "treatment instrument." based on the result of the legal manufacturer's investigation and device evaluation results, the likely cause of the event can be attributed to user handling and/or technique.As stated in the instructions for use, as a preventive measure: "if an endotherapy accessory cannot be withdrawn from the endoscope, close the tip of the endotherapy accessory or retract the tip of the endotherapy accessory into its sheath and slowly withdraw the endoscope while observing the endoscopic image.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and/or cause patient injury." "if the insertion or withdrawal of endotherapy accessories is difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories, cause some parts to fall off and/or cause patient injury.".

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10670538
• MDR Text Key: 223663006
• Report Number: 8010047-2020-07616
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 09/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2013
• 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