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

Model Number CYF-VHA

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp.For evaluation.The manufacturing record of the subject device was reviewed with no irregularity.Since this spring, the newly appointed physician sometimes reportedly inserts a scope with excessive force during cystoscopy.Therefore, the user facility thought the handling might be the cause.The user facility considered the possibility that microorganism remained in the subject device, because the number of the patients who became prostatitis was large.The user facility reported that water sometimes dropped from the subject device due to insufficient drying as the subject device was put and stored on the table after reprocessing.Therefore, the subject device was reprocessed by aer (automated endoscope reprocessor) before use, but the reprocessing is not conducted recently.A service personnel from olympus checked the procedure of reprocessing at the user facility and the followings are noted.The user facility does not carry out disinfection in the water supply line of the aer.Forceps/irrigation plug is not disassembled during reprocessing.The aer displays e99.(this message is displayed on aer when the number of days after disinfectant replacement or the number of times of use is too many.) the exact cause could not be conclusively determined at this moment, but it might be considered as a possible cause that there were some deviations from the instruction in reprocessing noted above.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus was informed on june 12, 2017 that 6 outpatients having undergone cystoscopy with the subject device developed prostatitis.Furthermore, the number of the patients who developed prostatitis was added as follows.Additional 2 patients information was reported on (b)(6) 2017.Additional 1 patient information was reported on (b)(6) 2017.Additional 8 patients information was reported on (b)(6) 2017.Surveillance culturing tests were conducted for the subject device and an automated endoscope reprocessor by the user facility, but no microorganism was detected.Olympus obtained the following information on 6 out of 17 patients.This is 1 of 17 reports.Patient a: escherichia coli were detected from the patient.The user facility conducted cystoscopy for the male patient and the procedure was completed without irregularity on (b)(6) 2017.Symptoms of fever around 39 degree and urination pain appeared, and the patient was diagnosed as having prostatitis on (b)(6) 2017.The patient was not hospitalized, but an antibiotic was administered on (b)(6) 2017.The patient recovered on (b)(6) 2017.Patient b: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017.Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis on (b)(6) 2017.Patient c: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017.Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis on (b)(6) 2017.Patient d: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017.Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis on (b)(6) 2017.Patient e: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017.Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis.The date is unknown.Patient f: the user facility conducted cystoscopy for the patient and the procedure was completed without irregularity on (b)(6) 2017.Symptoms of fever and urination pain appeared, and the patient was diagnosed as having prostatitis.The date is unknown.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The device referenced in this report has been returned to olympus medical systems corp.For evaluation.During the evaluation, it was confirmed that there were scratches inside the wall of the instrument channel, there was a kink in the insertion tube near the boot, and there was foreign material attached on the universal code.It was also confirmed that the rubber cover around the instrument channel port was misaligned and a biopsy forceps was caught inside the instrument channel while inserting.The relationship between the confirmed results and the patient outcomes is unknown.This report is 12 of 17 reports.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: 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: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6700105
• MDR Text Key: 79666514
• Report Number: 8010047-2017-00876
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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