MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS; GAS/WATER VALVE

Model Number MAH-2010

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

Olympus was informed that during colonoscopy, when the physician inserted the colonoscope, though the subject device attached to the scope was not being operated, the patient's sigmoid colon swelled.The facility was aware that the subject device was improperly attached to the colonoscope.Olympus was informed that the patient complained about pain when a sigmoid colon swelled, however there was no patient injury reported.

Manufacturer Narrative

Four pieces of maj-2010 including the subject device used in the user facility were returned to manufacturer for evaluation.As the result of the evaluation, it was revealed that there were no damage of deformation observed with all four units, and that there was no irregularity found.One of the returned devices were attached to a colonoscope of the same model as used in the reported event to test aspiration of co2 gas.As the result, it was confirmed that the reported phenomenon reproduced when the subject device was improperly attached.Based on the above, it could not be ruled out as a contributory factor to the event, that the subject device was improperly attached to the colonoscope.

Manufacturer Narrative

Olympus medical systems corp.(omsc) performed mdr retrospective review and omsc found that this supplemental report is required on december 2, 2015.

• Brand Name: OLYMPUS
• Type of Device: GAS/WATER VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4259147
• MDR Text Key: 4991355
• Report Number: 8010047-2014-00695
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAH-2010
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/22/2014
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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