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

Model Number CYF-VA2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

This device referenced in this report has not been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.The facility continues using the device, however there was no patient harm reported such as inflammation of the prostate.The service person checked the device with no irregularities found on the day the event was reported.The manufacturing history was reviewed with no irregularities found.Please cross reference the associated complaint file: mfr report#:8010047-2015-01162.

Event Description

Olympus medical systems corp.(omsc) was informed that two patients having undergone urinary bladder and urethra inspection developed inflammation of the prostate from a nurse when the service person visited the facility.At that time when the two patients had endoscopic inspection, the facility used two cyf-va2s (serial #(b)(4) manufactured on sep.6th in 2006 and #(b)(4) manufactured on jan.6th in 2012) and the facility could not identify which scope was used to each patients.1st patient (70's): about one week after having undergone endoscopic inspection, the patient developed fever.The patient came back to the facility and was diagnosed with inflammation of the prostate.The patient was infused antibiotic substance without being hospitalized.The patient became less severe.2nd patient ((b)(6) years old): about ten days after having undergone endoscopic inspection, the patient developed fever.The patient came back to the facility and was diagnosed with inflammation of the prostate.The patient was hospitalized and was infused antibiotic substance.The patient was in follow-up.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5269845
• MDR Text Key: 32737926
• Report Number: 8010047-2015-01163
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K#:K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CYF-VA2
• Device Catalogue Number: CYF-VA2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR