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

Model Number CYF-VHR

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/08/2021

Event Type  Injury  

Event Description

It is reported in mw5101053, after reprocessing a cysto-nephro videoscope, black specks were noted.Additional information received from the customer: the cystoscopy was being performed for the indication of : bladder cancer.There were no black specks found pre-procedure.During the procedure, a black speck was found floating in the bladder.The surgeon removed the back speck with a syringe.One dose of amoxicillin by mouth was given post procedure.The patient has experienced no adverse effects as a result of this occurrence.The patient's current condition is described as: no adverse events at this time.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 (this report is associated with manufacturer's report 8010047-2021-07230).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: 12314265
• MDR Text Key: 266361547
• Report Number: 2951238-2021-00379
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411298
• UDI-Public: 04953170411298
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2021,08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2021
• Is the Reporter a Health Professional?: Yes
• 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: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 109