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

Model Number CYF-VA2

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the visera cysto-nephro videoscope had insufficient angulation downwards.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: a shaved forceps channel port.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found a shaved forceps channel port.In addition to the reportable malfunction, the following were noted: the switch box had discoloration and a scratch; the bending section cover had slack; the bending section cover adhesive had a chip; the connecting tube had a dent and a wrinkle; the upward/downward angulation plate had discoloration; the video cable had a wrinkle and a scratch.Additionally, the following components had a scratch: the angulation lever, the control unit, the forceps elevator lever, the grip, the light guide connector, the protector of the universal cord on the control section side, the scope cover, the universal cord, the video connector case, and the video connector.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu) with the following warning: "¿ if resistance is encountered and insertion becomes difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting endotherapy accessories with excessive force may damage the endoscope and/or accessory.¿ confirm that the tip of the endotherapy accessory is closed or retracted into its sheath.Slowly insert the endotherapy accessory into the forceps/irrigation plug.Do not open the tip of the endotherapy accessory or extend the tip of the endotherapy accessory from its sheath while inserting the endotherapy accessory into the instrument channel.The instrument channel and/or the endotherapy accessory may be damaged." olympus will continue to monitor the field performance of this device.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17879564
• MDR Text Key: 325024362
• Report Number: 3002808148-2023-10833
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339455
• UDI-Public: 04953170339455
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2023

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-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2012
• 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