MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO6 REGULATION UNIT; CO2 REGULATION UNIT

Model Number UCR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/06/2017

Event Type  Death  

Manufacturer Narrative

The facility has no plan to return the referenced ucr to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the ucr.However, on (b)(6) 2017, the olympus field service engineer confirmed that all ucrs (including the referenced the ucr) did not have any problem as routine inspection.Also, prior to use of the procedure, the facility checked the referenced ucr and found the no problem.Also the physician stated that during the procedure there was not any defect of the devices, and the facility was continuing to use the ucr.Therefore the referenced ucr had no malfunction.The exact cause of the reported event could not be conclusively determined at this time.However there is the possibility of this phenomenon is attributed to the patient¿s condition.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The patient had undergone the ileal conduit diversion as the urinary diversion after the total cystectomy.The patient had evidence of anemia, and the anastomotic hemorrhage from ileum and/or stoma was suspected as the cause of anemia.Therefore the emergency endoscopy was performed in combination with the ucr.During the endoscopy with inserting the endoscope from the patient¿s stoma, the patient experienced a drop in blood pressure and then fell into critical condition.A few days after, the patient deceased.According to the result of the autopsy of the patient, there were air emboli in the kidney and the brain, and also the subdural hematoma.

Manufacturer Narrative

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

• Brand Name: ENDOSCOPIC CO6 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• 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 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6659470
• MDR Text Key: 78126596
• Report Number: 8010047-2017-00764
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK102763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UCR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/10/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR