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

Model Number CYF-V2

Device Problems Endoscope (802); Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Type  Malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation. The evaluation confirmed the reported scope damage. A cut was found on the bending section cover measuring approximately 20mm from the distal end; however no metal wires were found protruding from the scope. In addition, the bending section cover glue was found with cracks and missing portions on both the distal end and insertion tube of the scope. It was also noted that glue was found missing on the objective lens. To add, there were multiple buckles found on the insertion tube. The scope was serviced and returned to the user facility. As part of our investigation, an olympus endoscopy support specialist (ess) visited the user facility and provided a reprocessing in-service on (b)(6) 2017. The user facility did not want olympus to observe their reprocessing practice, therefore only a reprocessing training in-service was performed by the ess. Based on similar reported events, the cause of the reported event is likely attributed to user handling and improper maintenance of the device. The instruction manual for use provides several warning and caution statements in an effort to prevent scope damage. ¿the probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each facility should inspect the items specified in this manual periodically. An endoscope with an observed irregularity should not be used, but should be inspected by following section 9. 1, ¿troubleshooting guide¿ on page 119. If the irregularity is still observed after inspection, contact olympus. Do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, and control section with excessive force. The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation. It could also cause parts of the endoscope to fall off inside the patient. ¿.

Event Description

Olympus was informed that during a diagnostic cystoscopy procedure, a piece of the bending section rubber broke off inside the patient¿s bladder when the scope was being removed from the patient. The device fragment was not retrieved. The physician stated that the device fragment would pass naturally. The procedure was completed using the same scope. To add, it was reported that the scope was inspected prior to use.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from nwb to faj and 510(k) number.

• 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-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6609639
• MDR Text Key: 76634200
• Report Number: 2951238-2017-00387
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL,USER FACI

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/02/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: CYF-V2
• Device Catalogue Number: CYF-V2
• Device LOT Number: N/A
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse