MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number SIF-Q260

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, the evis lucera small intestinal videoscope had a cut on the image guide protector.There were no reports of patient harm.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: there was a foreign object inside the nozzle.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed due to physical stress.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: due to wear of angle wire, bending angle in up direction and the play of upward/downward did not meet the standard value; adhesive on the bending section cover had a chip and crack; plastic distal end cover, connecting tube, suction connector, protector of universal cord on suction connector, universal cord, grip, scope cover, switch box, free-engage knob, upward/downward angulation control knob, right/left knob, and control unit had a scratch; objective lens and control unit had discoloration; suction cylinder was shaved; due to dirt on the objective lens, there was a lack of image on the monitor; and due to a scratch on the objective lens, the image had a dark area partially.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Attempts were made to obtain additional information regarding the customer's cleaning, disinfection, and sterilization processes, but no response was received from the customer.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.It has been over 9 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the foreign material could not be identified.Moreover, it is unknown if the reprocessing was conducted in accordance with the ifu (instructions for use) from the obtained information.Hence, a conclusive root cause of the foreign material remained in the device could not be determined.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: ifu states that detection method in sif-q260 operation manual chapter 3 preparation and inspection.Ifu states that preventive measure in sif-q260 reprocessing manual chapter 3 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• 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: 18385480
• MDR Text Key: 331389967
• Report Number: 9610595-2023-20248
• Device Sequence Number: 1
• Product Code: FDA
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIF-Q260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2014
• 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