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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 11/30/2016
Event Type  Injury  
Manufacturer Narrative

The legal document did not specify a model, serial or lot number for any of the devices that allegedly attributed to the patient¿s outcome. Therefore, it is unknown if the device was returned to olympus for evaluation, service or repair. In addition, as part of our investigation olympus followed up with (b)(6) and was informed by the facility¿s vice president of quality management that the facility does not use olympus equipment and therefore, cannot provide any details regarding the mentioned patient or procedure. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported events. If additional information becomes available, this report will be updated and supplemented accordingly.

 
Event Description

On (b)(6) 2018, olympus received a legal document that alleges during a cystoscopy with urethral dilation and transurethral resection/ablation of prostate with bipolar procedure, a patient sustained a thermal injury to the bladder and urethra. According the legal document, the patient was under anesthesia when the alleged injury occurred. It is unknown if the patient was treated or if intended procedure was completed.

 
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Brand NameVISERA CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-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
4089355124
MDR Report Key8188042
MDR Text Key131136607
Report Number2951238-2018-00784
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/20/2018 Patient Sequence Number: 1
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