MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H290

Device Problems Partial Blockage (1065); Failure to Clean Adequately (4048)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

Establishment name: (b)(6).The evaluation revealed: the customer reported air water supply issue was confirmed.Some foreign material inside the nozzle, but it could not be specified what the foreign material was.It was confirmed with the field service engineer that the customer facility is under remodel and there is no water treatment system in building 3, and the water pressure is insufficient, which often leads to blockage.Additionally, the angle was insufficient, play occurred during angulation, the leak check label inside the suction connector discolored, but the venting valve was normal.The concerned product has been repaired once in the past year.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported to olympus that after an unknown procedure, air/water could not pass the device smoothly.The facility completed the case with the same device and there was not a delay of more than 15 minutes.There was no death or injury reported due to the event.

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.The device met all specifications at the time of shipment.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the cause of the foreign material was likely from improper reprocessing after the previous procedure.The specific root cause of the improper reprocessing at the facility could not be determined at this time.The following information is stated in the instructions for use which may have prevented the event: "precleaning the endoscope and accessories: warning: if the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy.Preclean the endoscope and the accessories at the bedside in the patient procedure room immediately after each patient procedure.Caution: to prevent clogging of the air/water nozzle of the endoscope, flush water into the air channel of the endoscope, using the aw channel cleaning adapter (mh-948) after each patient procedure.Clean the external surfaces of the insertion section: while immersing the endoscope completely in the detergent solution, thoroughly wipe all external surfaces of the insertion section, using clean lint-free cloths or sponges.Take the insertion section out of the detergent solution and confirm that no debris remains on all external surfaces, particularly the air/water nozzle opening and the objective lens on the distal end.Flush the air/water channel with detergent solution, remove detergent solution from all channels.Presoaking the endoscope: if there was excessive bleeding during the patient procedure or if precleaning could not be performed immediately after the patient procedure, presoaking the endoscope in detergent solution before manually cleaning the endoscope may be required to wet and loosen debris that has dried and hardened onto the endoscope¿s surfaces.Follow the procedure described below." 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): 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: 14042922
• MDR Text Key: 288802938
• Report Number: 8010047-2022-05882
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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
• Date Returned to Manufacturer: 03/13/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2015
• 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