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

Model Number UCR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to (b)(4), however the subject device was not returned to olympus medical systems corp.(omsc) for evaluation yet.The subject device is now in transit from (b)(4) to omsc.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus was informed that four patients suffered injury during colonoscopies using with same ucr.In all four cases, the water was poured for cleaning of the patient¿s mucosa and co2 was insufflated into the patient with the ucr, then the patient¿s mucosa turned white and raised.Furthermore, in one of the four cases, the patient suffered rectal bleeding and was transported to the emergency room, however the medical intervention was not necessary.In another one of the four cases, the patient had abdominal pain for four days.All four patients recovered and became well.This report is 2 of 4, which is regarding the abdominal pain and the injury of the mucosa.

Manufacturer Narrative

The subject ucr was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the inside and exterior of the subject ucr visually, there was no abnormality and irregularity.Omsc confirmed the flow rate and the supply pressure of insufflation of the subject ucr and found that the flow rate and the supply pressure were within the specification.Furthermore, the subject ucr operated without any problem.Omsc checked the device history record of the subject ucr there was no irregularity found.The exact cause of this phenomenon could not be conclusively determined, however there was the possibility that this phenomenon was attributed to the cause except the subject ucr.Olympus stated the appropriate handling of ucr and the counter measures against abnormalities in the instruction manual of ucr.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8751574
• MDR Text Key: 149760241
• Report Number: 8010047-2019-02392
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: UCR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other