MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION VISERA CYSTO-NEPHRO VIDEOSCOPE; CYSTO-NEPHRO SCOPE

Model Number CVF-VA2

Device Problems Device Reprocessing Problem (1091); Device Disinfection Or Sterilization Issue (2909)

Patient Problems Fever (1858); Unspecified Infection (1930); Chills (2191)

Event Date 09/28/2014

Event Type  Injury  

Event Description

Olympus medical systems cor.(omsc) was informed that after examination of bladder with the subject scope, the patient developed infection.He had an inspection on (b)(6) in 2014 and then three days later, he developed a fever.Since he had a positive test result for gnb (gram-negative bacillin), an antibiotic was prescribed for him.He seems to obtain medical care as an outpatient.On (b)(6) in 2014, olympus visited the facility to obtain detail information and check the reprocess procedure.It was revealed that the facility reprocessed a scope without detaching a forceps/irrigation plug.Since then, two scopes of cyf-va2 and two forceps/irrigation plugs had cultivation survey.As a result of survey, no bacterium was found from the two scopes, but pseudomonas aeruginosa was found from one of two forceps/irrigation plugs.There is no tracking data of which plug was used for the patient.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Based upon the evaluation of the subject device by omsc, it was confirmed that there were foreign substances in the opening of the instrument channel and in the suction cylinder.There was no abnormality such as breakage, deformation or scratches at the distal part, in the channel, in the instrument channel, instrument channel port or suction cylinder.The forceps/irrigation plug enclosed with the subject device was checked and there was a marked foreign substance.The facility reprocesses the forceps/irrigation plug without detaching from the scope and this does not conform to the written instruction manual.The manufacturing history was reviewed, with no irregularities related to this problem noted.Based on the findings, inappropriate handling by the user could not be ruled out as a contributory factor of the event.This report is being submitted as a medical device report in an abundance of caution.Please cross reference with manufacture report numbers, 8010047-2014-00685 and 8010047-2014-00687.

Manufacturer Narrative

Olympus medical systems corporation (omsc) performed a mdr retrospective review and omsc found that this supplemental report is required.This supplemental report is being submitted to correct from " malfunction" to "serious injury".

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO SCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4280846
• MDR Text Key: 5030088
• Report Number: 8010047-2014-00686
• Device Sequence Number: 0
• Product Code: FAJ
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CVF-VA2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 11/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR