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

Model Number CYF-V2R

Device Problems Crack (1135); Degraded (1153); Material Discolored (1170); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2022

Event Type  Injury  

Event Description

The customer reports during an unspecified procedure using a visera cysto-nephro videoscope, the end of the scope fold and was involved in an incident that harmed a patient.Additional detail regarding the patient and reported event have been requested.At this time, no additional information has been provided.The device was returned to olympus for physical evaluation.Olympus was unable to find any signs of the bending section cover stretched or folded.Instead, olympus observed the bending section cover to be a non-olympus repair/part.Additionally, the non-olympus bending section cover has multiple cuts (exposing the metal braid mesh), excessive cracks and discoloration were also observed with the bending section cover.In addition, the bending section cover glue is also discolored.The non-olympus bending section cover cause an irregular shape to the bending section itself.

• 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
• MDR Report Key: 15594881
• MDR Text Key: 301665487
• Report Number: 2429304-2022-00081
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339523
• UDI-Public: 04953170339523
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022,10/13/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other