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

Model Number TJF-Q180V

Device Problems Device Reprocessing Problem (1091); Corroded (1131); Microbial Contamination of Device (2303); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of returned device shows: the device failed the leak test inspection.The device passed the electrical safety testing.Other inspection points that failed include: the cover glass glue, the bending section rubber, the insertion tube and protector, the scope connector alignment, and the forceps raiser function (contamination).It was noted there was staining/surface damage/ delamination due to chemical damage.Microbiological testing of the returned device shows: during a microbiological test no germs have been found on this instrument.All channels have been checked without finding any germs.Preliminary investigation analysis: the root cause of the reported phenomenon cannot be conclusively determined, however, user's insufficient reprocessing cannot be ruled out as a contributing factor.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported by the customer an evis exera ii duodenovideoscope had three positive cultures for bacillus species.There is no patient contact/impact associated with these occurrences.

Manufacturer Narrative

This report is being submitted to repot investigation findings.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: be sure to perform a leakage test on the endoscope prior to manual cleaning.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.(reprocessing manual):3.5 manual cleaning brushing around the forceps elevator and instrument channel outlet states on detailed method for reprocessing forceps elevator and around the elevator.Reprocessing method for under the elevator is stated as follows: 7.While holding the distal end, insert the soft brush or the channel-opening cleaning brush (mh-507) or single use channel-opening cleaning brush (maj-1339) into the interior of the forceps elevator.Turn the inserted brush once, then pull it out.8.Brush both sides of the forceps elevator using the soft brush or the channel-opening cleaning brush (mh-507) or single use channel-opening cleaning brush (maj-1339) note: using the single use soft brush (maj-1888, sold separately) simplifies the cleaning procedure around the forceps elevator.Conclusion: the definitive root cause of the reported event could not be determined.Relation between the suggested event, positive culture test, and the subject device: we could not confirm relation between the event and the device by considering the following investigation results.Growth of microorganism was confirmed from culture testing by the user after reprocessing.When olympus culture tested the device after reprocessing in accordance with ifu before repair, growth of microorganism was not confirmed from each sampling.The device had leakage.Suggested event: inside of lg-lens is dirty since leakage from the device was confirmed, inner parts of lg-lens may have corroded by humidity invasion from the leak.The corrosion products may have remained as dirt.Suggested event: corrosion under the l-arm cover (foreign object adhered the distal end) since leakage from the device was confirmed, inner parts of arm cover may have corroded by humidity invasion from the leak or immersion of distal end.The corrosion products may have remained as dirt.

• Brand Name: EVIS EXERA II 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: 12558311
• MDR Text Key: 281205141
• Report Number: 8010047-2021-12527
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• 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: 09/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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