MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GAS/WATER VALVE

Model Number	MAJ-521
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined at this time.However, if the device is returned for evaluation at a later date, this report will be supplemented accordingly.As a preventive measure, the instruction manual for the device provides warning that state, "do not allow the pressure to exceed 50 kpa at any time during the procedure, and always monitor the pressure during the procedure.Otherwise, excess pressure can build up within the patient¿s body cavity and cause injury.It can also damage the water container and/or the endoscope.".
Event or Problem 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 2 of 2.

• Brand Name: GAS/WATER VALVE
• Common Device Name: GAS/WATER VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8961074
• Report Number: 8010047-2019-03192
• Device Sequence Number: 11478080
• Product Code: FET
• UDI-Device Identifier: 04953170071478
• UDI-Public: 04953170071478
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: MAJ-521
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention