MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device was inspected at olympus (b)(4).It was confirmed that it was found a wire of the composing the forceps elevator wire of the subject device was cut and then risen, and also found the dirt inside the light guide lens of the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The root cause of the reported phenomena could not be identified.However based on the report of olympus (b)(4), omsc presumed there was the possibility these phenomena were attributed to the following causes for each; [a wire of the composing the forceps elevator wire of the subject device was cut and then risen] -it was presumed that the wire might have been cut due to fatigue failure with repeated forceps raising operations, and the forceps elevator wire might have been raised due to repeated brushing cleaning around the forceps elevator and attachment / detachment of the distal end cover.[the dirt inside the light guide lens of the subject device] -due to physical stress, a gap might have been created in the adhesive part of the light guide lens, and dirt got in.-moisture infiltrated the inside of the subject device, which might have been corroded the internal components of the light guide lens and left its products as dirt.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed during the incoming inspection for repair at olympus (b)(4), that it was found a wire of the composing the forceps elevator wire of the subject device was cut and then risen, and also found the dirt inside the light guide lens of the subject device.The subject device had been sent to olympus korea for repair of the forceps elevator failure of the subject device.The occurrence date of the event is unknown.There was no patient injury associated with this report.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 12877887
• MDR Text Key: 283291000
• Report Number: 8010047-2021-15115
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• 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