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

Model Number	MAJ-1990
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To this date, this device has not been recovered and returned.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that after an endoscopic examination and inspection is over, this distal hood was missing.The endoscope was inserted again to the descending leg of the duodenum, but the hood could not be found.The patient refused additional procedure and was discharged home.A follow-up was approved.There were no reports of patient or user harm associated with this event.Case with patient identifier (b)(6) reports the distal hood used in the procedure.Case with patient identifier (b)(6) reports the evis lucera gastrointestinal videoscope used in the procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot 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, a root cause could not be identified.The attachment method for the distal cover (maj-1990), or some failure in the device may have caused the cover to fall off the scope.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿attaching and fastening to the endoscope: ¿ do not set the distal hood askew.¿ when a lubricant is applied, be sure to wipe off any excessive lubricant using a lint-free cloth before mounting the distal hood.If the lubricant is not completely wiped off, the distal hood may fall off during use and damage tissue inside the body cavity.Secure the distal hood to the endoscope¿s distal end with medical tape.¿ wrap the medical tape around the juncture of the distal hood and the endoscope tip 2 or 3 times.Make sure the juncture is positioned at the center of the distal hood and tip of the endoscope.¿ use medical tape with sufficient elasticity.¿ do not use vaseline® (or any chemical that contains petroleum jelly) or olive oil as a lubricant when it is difficult to mount the distal hood.¿ when mounting the distal hood on the endoscope, hold the endoscope as close to the distal end as possible to minimize the force applied to the bending section of the endoscope.Align the endoscope attachment section with the endoscope¿s distal end and press the distal hood as far as possible.¿ do not reuse since the medical tape is single use.¿ refer to the tables in section 2.2, ¿specifications¿ to confirm that these instruments are compatible with the ancillary equipment being used.¿ this supplemental report includes information added to d8.Also, a correction has been made to b5 to provide information that was inadvertently not included on the previous submission.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The following additional information was received: it was confirmed that the patient did not experience any health issues due to this incident.
Additional Manufacturer Narrative
This report is being submitted due to the additional information received that is reflected in b5.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
Olympus further received information that the patient was female, race and ethnicity is japan.

• Brand Name: DISTAL HOOD
• Common Device Name: DISTAL HOOD
• 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: 16134175
• Report Number: 9610595-2023-00547
• Device Sequence Number: 7654278
• Product Code: FDS
• UDI-Device Identifier: 04953170314407
• UDI-Public: 04953170314407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1990
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 12/26/2022
• Supplement Date Received by Manufacturer: 01/25/2023; 02/21/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 01/27/2023; 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H260Z WITH SERIAL NUMBER (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian