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

Model Number TJF-260V

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed during the incoming inspection for repair at (b)(4), that it was 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 broken forceps elevator.The occurrence date of the event is unknown.There was no patient injury associated with this report.

Manufacturer Narrative

The subject device was inspected at (b)(4).It was confirmed that there was 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 (b)(4) and the former events which had occurred at the user facility and the former similar case, omsc presumed that the reported phenomenon occurred by the following mechanism; physical stress was applied to the tip of the subject device.Due to the physical stress, the light guide lens was damaged, and a gap was created.Or, there was a gap in the light guide lens adhesive part.Dirt and moisture have entered the inside of the light guide lens through the above gap.In addition, the moisture caused the internal parts of the light guide lens to corrode, and the product was detected as dirt.[notes] since the instructions for safe use (ifu/operation manual) has the following description, it is probable that the reported phenomenon could be prevented.Important information please read before use: warnings and cautions: do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.If additional information becomes available, this report will be supplemented.

• 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: 12932024
• MDR Text Key: 281759770
• Report Number: 8010047-2021-15546
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1