MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO7 REGULATION UNIT; CO2 REGULATION UNIT

Model Number UCR

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

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

The referenced ucr was not returned to olympus medical systems corp.(omsc) for evaluation.However the technician of the olympus (b)(4) evaluated the ucr and found that, though the ucr had the damage and discoloration which were unrelated to the function, the ucr operated without problem and the function of the insufflation was correct.The exact cause of the reported phenomenon cannot be conclusively determined, however, according to the literature, it is known that abdominal pain is common complication after colonoscopy due to residual air in intestinal tract.The air is emitted, and then the abdominal pain will be resolved.Therefore omsc concluded that this phenomenon was attributed to common complication of colonoscopy.Olympus stated the appropriate handling of the ucr in the instruction manual.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

After the colonoscopy, the patient complained of severe abdominal pain.Other patient's injury and any medical intervention were not reported.

Manufacturer Narrative

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

• Brand Name: ENDOSCOPIC CO7 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: 6921385
• MDR Text Key: 88935478
• Report Number: 8010047-2017-01441
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: UCR
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1