MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H290

Device Problems Device Reprocessing Problem (1091); Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Address - full address name of the facility is (b)(6) medical university.Concomitant device - histoacrylic (surgical skin glue).Nm-610u-0425 (local injection needle).The subject device was received and evaluated.Device evaluation found clogged nozzle and clogged channel tube.Foreign material found inside the nozzle and forceps hole (ch-tube).Due to clogging of ch-tube, the tube cleaning brush cannot be inserted.The reported issue of "histo acrylic attached to the tip, also inside the forceps hole" was confirmed.Additionally, the following defects were identified during device inspection: adhesive on a-rubber (adhesive connection) has a chip.Objective lens has discoloration.Protector of universal cord on s-connector side has a scratch.Forceps channel port found shaved.Forceps elevator has scratch.Switch box has a scratch.S-connector has a scratch.Universal cord has a scratch.Grip has a scratch.Control unit has discoloration.Control unit has a scratch.Control unit has a scratch.Bending section (a-rubber) has a scratch.Distal end (c-cover)has a scratch.Connecting tube has a scratch.Suction cylinder found deformed.The reprocessing information and foreign matter surveys results obtained from the customer facility were noted below : device was cleaned, sanitized and disinfected prior to sending the device for repair.Facility aware of the foreign matter adhered on the device.(histoacrylic) the device was used for the procedure with the foreign material attached to it ¿ the facility noted ¿yes.¿ device was used with histoacrylic.The time lag between the end of clinical use and the start of pre-washing noted no delay, properly implemented.Flushed the air/water nozzle with water and air.Sent liquid to the air/water nozzle.Flushed air/water nozzle with detergent solution.Wiped/brushed the air/water channel with clean lint ¿free cloths, brushes, sponges.Facility noted normal, no abnormalities on the accessories used for reprocessing.Concerns regarding reprocessing- facility did not put any comments, no information was provided other than noting that the reprocessor used for cds is an oer-4, recommended by olympus.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Company representative reported with an issue of "histoacrylic (surgical skin glue) attached to the tip, also inside the forceps hole" and cannot be removed.According to the report, the user injected histoacrylic with a local injection needle.When tried to enter, from the target site, it leaked , and the attached histoacrylic adhered to the local injection needle got into the forceps hole of the scope.According to the report, the intended "hemostasis" procedure was completed by replacing the device (scope).No delay in the procedure was reported.Device inspected prior to use.No harm was reported.No patient harm, no user injury reported.Device evaluation found foreign matter clogging in the device nozzle and forceps hole.This report is being submitted due to the finding of foreign material in the nozzle (handling , device reprocessing issue ) identified during device return 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 foreign material was unable to be identified, and the foreign material itself was also unable to be identified.There were no noted deformations in the nozzle, instrument channel, or distal body.Based on the results of the investigation, the likely cause of the foreign material is due to insufficient or inadequate reprocessing.The events can be detected/prevented by following the instructions for use which describes how to inspect for the subject event in ¿chapter 3 preparation and inspection, section 3.3 inspection of the endoscope and section 3.8 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 section 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.2.Depress the valve.Observe the endoscopic image and confirm that water flows on the entire objective lens.The events can be detected/prevented by following the instructions for use which describes how to inspect for the subject event in ¿chapter 3 preparation and inspection, section 3.3 inspection of the endoscope and section 3.8 inspection of the endoscopic system¿ as below.[inspection of the endoscope] 1 inspect the control section and the endoscope connector for excessive scratching, deformation, loose parts, or other irregularities.[inspection of the instrument channel] 1 insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end.Also, make sure that no foreign objects come out of the distal end.2 confirm that the endotherapy accessory can be withdrawn smoothly from the biopsy valve.The events can be detected/prevented by following the instructions for use which describes how to inspect for the subject event in ¿chapter 3 preparation and inspection, section 3.3 inspection of the endoscope and section 3.8 inspection of the endoscopic system¿ as below.[inspection of the endoscope] 3 inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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: 16368796
• MDR Text Key: 309602157
• Report Number: 9610595-2023-02397
• Device Sequence Number: 1
• Product Code: FDS
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

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: Health Professional
• Device Model Number: GIF-H290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• 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
• Treatment: PLEASE SEE H10