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

Model Number GIF-XP290N

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned and evaluated.The reported allegation was not confirmed.However, the evaluation uncovered the following faults: the right/left knobs on the control section failed to operate smoothly, the play of the up/down knobs were out specification, and the adhesive of the rubber on the insertion section was peeled/cracked/chipped from wear.Additionally, the control and insertions of the device had numerous scratches.The investigation is ongoing.A supplemental report will be submitted upon completion.

Event Description

The customer reported to olympus that the angulation on evis lucera elite gastrointestinal videoscope became locked and was unable to disengage.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Ple 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.The reported event (angulation was locked on videoscope) was not reproduced during the device evaluation.However, based on the results of the investigation, it¿s likely the reported event temporarily occurred due to breakage of the angulation control knob and/or squashed insertion tube at insertion section as this could cause the angulation to be temporarily inoperable.It¿s probable the breakage of angulation control knob and squashed insertion tube at insertion section were caused by external stress.The root cause of this event was unable to be identified.The following is included in the instructions for use: ¿3.3 inspection of the endoscope: if the movement of the up/down angulation lock, right/left angulation lock, and the angulation control knobs is loose and/or not smooth, or the bending section does not angulate smoothly, the bending mechanism may have an irregularity.In this case, do not use the endoscope because it may be impossible to straighten the bending section during an examination.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information in b5, h6, and h10.

Event Description

Additional information was received which confirmed the event (angulation on subject device became locked and was unable to disengage) was identified upon inspection and testing of the customer returned device.There was no patient involvement.

• 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: 16072083
• MDR Text Key: 308530817
• Report Number: 9610595-2022-06283
• 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,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XP290N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2013
• 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