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

Model Number TJF-Q180V

Device Problems Crack (1135); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The user facility stated that the device had not completed reprocessing, and they performed only pre-cleaning with manual flushing outside the column.The reprocessing was not completed due to peristaltic pump malfunction due to "air leak" error.There was no delay in pre-cleaning phase, manual cleaning phase was not completed.The cleaning agent used was giozymax and the surface of the instrument was cleaned only by sponging.The device was returned to olympus for evaluation.In addition to the reported malfunction documented in b5, the additional evaluation findings are as follows: the forceps channel port had a dent, the air/water and suction cylinder had no color, the switch 1 had a pinhole, due to the guide pin of electrical connector was missing, water tightness was lost, the sheet holder unit had and the electrical connector both had corrosion due to water leakage, the distal end and the objective lens both had a crack, the light guide lens had a chip, the connecting tube had a wrinkle, and the universal cord had the coating peeling.The switch box, the right and left knob, the upward and downward knob, the scope cover, the grip, and the suction connector all had a scratch.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported to olympus that the duodenovideoscope had pneumatic leakage at the protective cap area.The event was found during reprocessing.There were no reports of patient harm.The device was returned for evaluation.During the evaluation the following reportable malfunction was found; the distal end had a crack and the adhesive around light guide lens had foreign objects.This medical device report (mdr) 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.It has been over 9 years since the subject device was manufactured.Issue 1 (distal end cracked) ¿ based on the results of the investigation and the additional damage noted during the evaluation, this is consistent with the crack having occurred as a result of physical stress.However, specific root cause of the damage could not be determined.Issue 2 (light guide lens glue had foreign material) ¿ based on the information provided from the customer, the cause of the foreign material remaining was identified as the device not being completely reprocessed prior to being sent to olympus.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 18556662
• MDR Text Key: 333438262
• Report Number: 9610595-2024-01376
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2014
• 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