MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISTAL COVER

Model Number	MAJ-411
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) visited the facility and found the deterioration of the maj-411.The fse also confirmed that it can be attached and detached normally by replacing it with a new one.The maj-411 was not returned to any of olympus locations because the user had discarded the maj-411.Therefore, olympus could not investigate the maj-411.The exact cause of the reported phenomenon could not be conclusively determined.Omsc surmised that this phenomenon was attributed to the followings.The user attached the maj-411 that had something failure such as cracks or deformation.The maj-411 was forcibly attached with the instrument channel outlet of the jf-260v was closed (the forceps elevator was raised).The maj-411 was not securely attached to the distal end of the jf-260v.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during an endoscopic retrograde cholangiopancreatography (ercp) using duodenovideoscope (jf-260v) and the distal cover (maj-411), it was found that the maj-411 came off.The user did not notice the phenomenon during and immediately after the procedure, but after that noticed when the patient vomited the maj-411.The occurrence date of event is unknown.There was no report of patient injury associated with the event.

• Brand Name: DISTAL COVER
• Common Device Name: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12148180
• Report Number: 8010047-2021-08683
• Device Sequence Number: 3712889
• Product Code: FET
• UDI-Device Identifier: 04953170071416
• UDI-Public: 04953170071416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-411
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1