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

Model Number TJF-260V

Device Problems Contamination /Decontamination Problem (2895); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Device inspection found there is gap at the adhesive part of ar.The inside of the light guide (lg) lens were found dirty.Furthermore, the following findings were noted during device inspection: angulation in the up direction is out of standards due to worn of angle-wire.Insertion quantity is out of standards due to damage of channel tube.Liquid leaks due to cutting part of connecting tube.Screen is partly dark due to scratch of ccd lens.Ob lens scratched and chipped.A-rubber glue chipped.There is crease at the connecting tube.There is crease at the universal code.There is corrosion at the el-connector due to leakage.Color ring cracked: leak at distal end observed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported the adhesive part of ar (a-rubber) is peeled off.The issue found during receipt inspection.There is no patient involvement associated on this event.Device evaluation found the inside of lg (light guide) lens is dirty.This report is being submitted for the inside of light guide lens is dirty.

Manufacturer Narrative

Correction: g2 (correcting "korea" to "south korea").This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been caused by the influence of liquid or moisture from a leak into the inside of the subject device - this led to corrosion of the internal components of the light guide (lg) lens.Particles produced by corrosion were detected as dirt.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction: this report is being supplemented to provide information that was inadvertently left out of the initial medwatch and the supplemental medwatch.Information provided in g2.During the device evaluation, service found that the forceps could not be inserted or removed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, although a conclusive root cause could not be determined, it is likely the forceps could not be inserted or removed due to following: - the event occurred due to deformation of the forceps channel.- the event occurred due to breakage of the instrument.- the event occurred due to foreign material in the forceps channel.The following information is stated in the ifu (instructions for use) which may help to prevent the issue: operation manual 3.8 inspection of the endoscopic system - inspection of the instrument channel and forceps elevator operation manual important information ¿ please read before use - precautions operation manual 3.6 inspection of ancillary equipment operation manual 4.3 using endotherapy accessories reprocessing manual 5 reprocessing the endoscope (and related reprocessing accessories) reprocessing manual 7 reprocessing endoscopes and accessories using an aer/wd olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• 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: 13350360
• MDR Text Key: 294784048
• Report Number: 8010047-2022-01973
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2008
• 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