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

Model Number UCR

Device Problem Pressure Problem (3012)

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

The referenced device was not returned to the manufacturer for evaluation.The exact cause of the reported event cannot be determined at this time.However, if the device is returned at a later date, this report will be supplemented accordingly.As a preventive measure, the instruction manual provides warning that states, "anytime you observe an irregularity in the endoscopic co2 regulation unit, immediately stop using the endoscopic co2 regulation unit and withdraw the endoscope from the patient slowly as described in the endoscope¿s instruction manual.".

Event Description

The manufacturer became informed that 24 hours after a diagnostic colonoscopy procedure in (b)(6) 2019, a patient experienced pain and was inspected.The doctor at the user facility indicated that the patient was determined to have a perforated rectum and the doctor believed the injury to the patient was caused by over pressure from the endoscopic co2 regulation unit and gas / water valve.The patient was admitted to a different hospital / surgeon and required a exploratory laparotomy.The patient was hospitalized for a few weeks and discharged as the patient also had a pre-existing condition of severe arterial vascular disease in the lower extremities that eventually required amputation of one his legs.The technicians at the user facility performed a functional inspection prior to procedure and there were no anomalies noted.The doctor noticed that there was pressure being lost at the time but wasn't sure what it was, but the doctor later believed it to be pressure being lost from the perforation to the patient.This is for report 1 of 2.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8960991
• MDR Text Key: 156473040
• Report Number: 8010047-2019-03191
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2019

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: 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: 08/07/2019
• Initial Date FDA Received: 09/04/2019
• 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
• Treatment: GAS/WATER VALVE: OLYMPUS MAJ-521
• Patient Outcome(s): Hospitalization; Required Intervention