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

Model Number CYF-VA2

Device Problem Material Fragmentation (1261)

Patient Problem Unspecified Infection (1930)

Event Date 09/16/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.The evaluation found that there were several scraped parts inside the instrument channel.Buckling of the instrument channel was also found.There was chipping part on the adhesive on the both ends of the bending rubber, and it became lusterless.The coating of the insertion tube was slightly floating.The control section became lusterless.The manufacturing history of the subject device indicates no anomaly.The exact cause of the event could not be determined at this time.If additional and important information becomes available, a supplemental report will be submitted.Please cross reference the following mdr report number#: 8010047-2016-01318.

Event Description

Olympus was informed the following information that two patients who underwent cystoscopy using the subject device were infected with pseudomonas aeruginosa.First patient had a cystoscopy on (b)(6) 2016.The patient's condition became worse afterwards and returned to clinic on (b)(6).The patient was diagnosed as urinary-tract infection from pseudomonas aeruginosa and admitted into the hospital, receiving antibiotics.Second patient had a cystoscopy on (b)(6) 2016.The patient's condition became worse afterwards and returned to clinic on (b)(6).The patient was diagnosed as urinary-tract infection from pseudomonas aeruginosa and admitted into the hospital, receiving antibiotics.Both patients have bladder cancer.Culture test of the subject device, aer and hand wash sink was performed on (b)(6) 2016.Aer and hand wash sink tested positive for pseudomonas aeruginosa.

Manufacturer Narrative

Olympus service division investigated the subject device.At the inspection of angulation, deterioration of angulation range was confirmed and it was determined that it needs repair.At the whole visual inspection, scratches and crashing of the light guide tube, and damage of the angulation control lever were confirmed.They were determined that they need repair.Scratches on the video connector, smear on the control section and the grip cover were also confirmed but they were within the specification.At the inspection of outer view of the insertion portion, a pinhole on the angulation rubber, a chipping of the adhesive on the angulation rubber, and peeling-off of the coating on the universal cord were confirmed and they were determined that they need repair.At the inspection of outer view of the distal end, cracking of the light guide lens was confirmed and it was determined that it needs repair.At the inspection of insertion performance of an instrument and brush, the instrument was confirmed to be caught in the subject device, and the subject device was determined that it needs repair.At the water leak test, air leak form the angulation rubber was confirmed and it was determined that it needs repair.The exact cause of the phenomenon could not be determined at this time.The possibility cannot be ruled out that it was caused by an insufficient reprocessing associated with the condition of the device such as a pinhole on the angulation rubber and cracking on the light guide lens etc.Please cross reference the following mdr report number#: 8010047-2016-01318.

• 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: 6039318
• MDR Text Key: 57789726
• Report Number: 8010047-2016-01319
• Device Sequence Number: 1
• Product Code: NWB
• 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,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-VA2
• Device Catalogue Number: CYF-VA2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2006
• 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): Other