MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. DISTAL COVER

Model Number	MAJ-411
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only one (1) distal cover malfunctioned.The facility did not know which of the four (4) distal covers at the facility malfunctioned.Therefore, four (4) distal covers would be sent for evaluation.The device was returned to an olympus service center for evaluation and the reported issue was not confirmed.The distal cover satisfied the specified value of fixing strength.There was no problem with the locking mechanism of the caps.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, after use and during bedside cleaning, the distal cover came off just by gently stroking the tip of the evis lucera duodenovideoscope.The customer stated the distal cover may come off too easy.No patient injury reported.It was unclear whether the issue was due to the distal cover or scope.This complaint is related to patient identifiers; (b)(6)(evis lucera duodenovideoscope, jf-260v), (b)(6) (distal cover, maj-411), (b)(6) (distal cover, maj-411), (b)(6) (distal cover, maj-411).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the definitive root cause of the distal cover issue could not be determined.The lock mechanism of the cover did not have any problem.It is possible that there was an imperfection of the attachment method of the cover, which may have led to unfixing of the cover to the hook at the distal end of the scope, and the lock of the detachment prevention was not engaged.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device history record was unable to be reviewed for this device since the serial number was unknown.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the distal cover detachment could not be determined.It is possible that imperfection of the attachment method of the cover may have led to the unfixing of the cover to the hook at the distal end of the scope, which did not engage the detachment prevention lock.The maj-311/maj 411 abridged instruction manual identifies verbiage which may have prevented the phenomenon.Olympus will continue to monitor field performance for this device.

• Brand Name: DISTAL COVER
• Common Device Name: DISTAL COVER
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15122055
• Report Number: 9610595-2022-00372
• Device Sequence Number: 7372381
• Product Code: FET
• UDI-Device Identifier: 04953170071416
• UDI-Public: 04953170071416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-411
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 09/12/2022; 10/31/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 10/11/2022; 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown