MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

Device Problems Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of forceps did not come out was not confirmed.In addition to evaluation in b5, due to wear of angle wire, bending angle in up direction did not meet the standard value.The adhesive on bending section cover had a chip.The adhesive on the bending section cover had a crack.Adhesive on bending section cover had white-clouded area.The color ring had a crack.Connecting tube had a scratch.Forceps elevator had a scratch.Light guide lens had a scratch.The adhesive around light guide lens had peeled.Electrical connector had discoloration due to water leakage.The color ring had a crack.Switch button 3 had a scratch.Forceps channel port was shaved.The universal cord had a scratch.Image guide protector had a scratch.Protector of universal cord on scope connector side had a scratch.Reprocessing of subject device the customer was able to clean, disinfect and sterilize the subject device prior to sending it to olympus.User facility does not know when foreign object adhered to the scope.There was no delay between the end of clinical use and the start of pre-cleaning.The air/water nozzle was flushed with water and air.There were no abnormalities in the accessories used for reprocessing.The air/water nozzle was wiped/brushed with clean lint-free cloths, brush, or sponge.The air/water nozzle was flushed with a detergent solution.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A customer reported to olympus, the forceps would not come out the evis lucera duodenovideoscope.There was no report of patient harm associated with this event.During incoming inspection, foreign objects clogged the nozzle due to insufficient cleaning.This medwatch is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

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.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to insufficient or inadequate reprocessing the event can be detected by following the instructions for use (ifu) which state: ¿chapter 3 preparation and inspection, section 3.2 inspection of the endoscope and section 3.6 inspection of the endoscopic system¿ as below.[inspection of the endoscope] 8.Inspect the air/water nozzle at the distal end of the endoscope¿s insertion tube for abnormal swelling, bulges, dents or other irregularities.[inspection of the objective lens cleaning function] 1.Keep the air/water valve¿s hole covered with your finger and depress the valve.Observe the endoscopic image and confirm that water flows on the entire objective lens.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16755297
• MDR Text Key: 313643599
• Report Number: 9610595-2023-06248
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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: 03/19/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• 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