MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA DUODENOVIDEOSCOPE

Model Number TJF-160F

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature article titled "inspection of endoscope instrument channels after reprocessing using a prototype borescope", debris was found inside olympus scopes after reprocessing.Background/aim of study: visual inspection of the instrument channel has been proposed as a quality assurance step during endoscope reprocessing.However, the nature and severity of findings in a broad array of endoscopes (gastroscopes, colonoscopes, duodenoscopes, and echoendoscopes) after systemic implementation of an inspection protocol remain unknown.In addition, a study using borescope inspection in upper endoscopes and colonoscopes raised concerns about persistent simethicone residue despite full reprocessing.Methods: a pilot inspection study using a prototype borescope (stericam inspection scope; steriview inc, san rafael, calif) was performed on routinely used endoscopes after high-level disinfection, manual forced-air dry of the instrument channel, and overnight vertical storage.Video recordings 1.5 to 2 minutes in duration were reviewed for visible moisture, debris, discoloration, scratches, channel shredding (scratches that result in strips or filaments of the channel lining protruding into the lumen), and visible evidence of biofilm or simethicone residue.No human subjects.Results: a total of 97 inspections of 59 endoscopes were reviewed.The most common finding was scratches, seen in 51 devices (86%).Channel shredding was found in 35 devices (59%).Intrachannel debris was identified in 22 (23%) of the 97 inspections.No moisture was seen (0%) in the 74 inspections performed after forced-air dry and overnight vertical storage compared with moisture in 5 of 18 inspections (28%) performed after storage alone.No visual evidence of biofilm or simethicone residue was discovered despite its frequent use in our unit.Conclusion: internal defects of the instrument channel appear to occur frequently.Manual forced-air drying of the channel appears to be highly effective in eliminating moisture compared with overnight hang drying alone.Video inspection of the endoscope channel may be useful to audit reprocessing performance and to identify damaged endoscopes.Case with patient identifier (b)(6) reports tjf-160f found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports gf-uc140p-al5 found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports gf-uct140-al5 found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports gif-1th190 found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports gif-h180 found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports gif-hq190 found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports gif-q180 found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports cf-h180al found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports cf-hq190l found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports pcf-h190dl found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports pcf-h190l found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports tjf-180v found to have debris present inside after reprocessing.Case with patient identifier (b)(6) reports cf-q160 found to have debris present inside after reprocessing.

Manufacturer Narrative

This report is being updated to provide investigation results.New information is reported.The device history record (dhr) for the complaint device could not be reviewed since the serial number was not provided.Olympus does not ship any device that does not meet all design and safety specifications conclusion: the definitive cause of the reported events could not be established.

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 11768470
• MDR Text Key: 276136614
• Report Number: 8010047-2021-05783
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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