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

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.

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
• MDR Report Key: 8188042
• MDR Text Key: 131136607
• Report Number: 2951238-2018-00784
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability