MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-24 for VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2 manufactured by Olympus Medical Systems Corp..
[109228178]
Olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. The scope (cyf-v2, sn# (b)(4)) has not been returned to olympus for evaluation. As part of our investigation, a review of the device service history was performed and found no information on the reported scope. In addition, an olympus endoscopy support specialist (ess) provided a routine reprocessing in-service at the user facility on january 18, 2018 to observe the facility? S reprocessing practice and to provide a reprocessing training. During the in-service, the ess found that the staff did not have a leak tester and are not leak testing their scopes as stated in the instruction manual. The user facility staff was also not using a detergent. In addition, the staff was using reusable brushes to manually clean the scopes; however, the brushes were not being sterilized after use. The ess made the recommendation to purchase a leak tester, to purchase a detergent, to sterilize their reusable brushes or purchase single use brushes, and to switch from cidex opa to aldahol as cidex opa is not recommended for sure since the user facility performs many procedures on patient's with bladder cancer. The user facility declined to purchase a leak tester. The user facility did purchase aldahol; however, the aldahol test strips were returned. On may 10, 2018 the ess returned to the user facility to follow up on the initial reprocessing recommendations. The ess found that the user facility is now sterilizing their reusable brushes and following the correct cleaning and disinfection process; however, the ess found that the facility? S reprocessing area is located in the same room where procedures takes place. To add, the scopes are stored in a different procedure room and not in an enclosed ventilated cabinet. The ess made a recommendation to the staff to follow the reprocessing protocol as stated in the instruction manual. The ess also recommended the user facility to consult with an infection control preventionist and to have a designated separate room as their reprocessing area to prevent cross contamination. The user facility declined a reprocessing in-service during this visit. Based on the ess findings, the most likely cause for the reported patient infections is likely related to misreprocessing and improper maintenance of the scope. The instruction manual provides several warning statements in an effort to prevent patient infection and cross contamination. ? Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure may compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each procedure the endoscope and its ancillary equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization as described in chapter 7,? Cleaning, disinfection, and sterilization procedures?. Reprocess not only the external surface of the endoscope but also all channels. Be sure to perform a leakage test on the endoscope prior to manual cleaning. Do not use the endoscope if a leak is detected. Use of an endoscope with a leak poses an infection control risk to patients and operators and may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.? If the scope is returned at a later time, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[109228179]
Olympus was informed that an unspecified number of patient infections occurred at the user facility with the use of olympus cystoscopes during an unspecified number of procedures. The types of patient infections are unknown and the exact model and serial number of the cystoscope that caused or contributed to the patient infections are also unknown. However, it was determined that a total of three olympus cystoscopes are in use at the user facility. Olympus was further informed on (b)(4) 2018 that there were 3 pseudomonas infections and a potential urinary tract infection uti/pid; however, the uti incident has not been confirmed. Olympus is filing three reports to account for the three infected patients and reported cystoscopes. This is report 1 of 3.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00314 |
| MDR Report Key | 7543477 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-24 |
| Date of Report | 2019-03-01 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2018-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISERA CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2018-05-24 |
| Model Number | CYF-V2 |
| Catalog Number | CYF-V2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-24 |