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

Model Number CYF-VHR

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/08/2021

Event Type  Injury  

Event Description

It is reported during a cystoscopy procedure using a cysto-nephro videoscope, at the end of the procedure, a black speck was noted to be floating in the patient's bladder.The physician believes he removed the speck from the bladder with a syringe.The scope was removed, and when wiping the scope, black residual/specks were noted on the 4x4 gauze by the surgical technician (st).The st had inspected the scope prior to the procedure for residual/specks and none was found.The patient was made aware of the speck found in the bladder.The physician ordered amoxicillin 500mg by mouth for one dose.No further consequences to the patient have been reported.Additional details have been requested regarding the patient and reported event.At this time, no additional information has been provided.

Event Description

Additional information: in mw5101053, this facility reports 6 cases.Report with patient identifier (b)(6) reports case 1 of 6.Report with patient identifier (b)(6) reports case 2 of 6.Report with patient identifier (b)(6) reports case 3 of 6.Report with patient identifier (b)(6) reports case 4 of 6.Report with patient identifier (b)(6) reports case 5 of 6.Report with patient identifier (b)(6) reports case 6 of 6.

• 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: 11939824
• MDR Text Key: 254480524
• Report Number: 2951238-2021-00345
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411298
• UDI-Public: 04953170411298
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/13/2021,06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2021
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention