MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number	D-201-12704
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	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was returned to olympus for evaluation and the allegation was not confirmed.The subject device was manufactured in march 2023 based on the provided 3-digit lot information.The shape of the actual product was visually checked, and the inner diameter dimensions of the actual product were measured, but there were no abnormalities.The actual product was stained all over.The actual product was attached to an endoscope pcf-h290i (serial number: (b)(6)) owned by aomori olympus and at this time, no abnormalities such as loose attachment was observed.The endoscope was shaken strongly about 5 times without fixing the actual product with medical tape, but the actual product did not fall off.The force when removing the actual product from the endoscope was also measured without fixing it with medical tape, and there was no problem with the force.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus that the disposable distal attachment fell out within the patient's body immediately after insertion.The fallen item was recovered, and the unspecified procedure was completed with similar equipment.There was no effect to the patient.There was no further harm or user injury reported due to the event.At the time of inspection before use, the device reportedly felt loose, and even though it was firmly attached, the above issue occurred.After checking with the person in charge of the facility, they also checked other identical products, but only the actual product was found to be loose.
Event or Problem Description
It was reported that the patient was undergoing a diagnostic colon (lower part) screening procedure.The distal attachment fell into the duodenum and was retrieved by biopsy forceps.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information and correction to the initial medwatch with information inadvertently missed.Please see b5.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h6 a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over one (1) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined, and due to the force of withdrawing the product from the endoscope, no abnormalities were detected.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use: ¿ do not use vaseline (or any lubricant that contains petroleum jelly), olive oil, alcohol, or the xylocaine spray to lubricate the instrument.Doing so could cause equipment damage or cause the instrument to fall off of the endoscope inside the patient.Be sure to wipe away any excess lubricant before mounting the instrument and secure the instrument firmly using medical tape with sufficient elasticity.If the instrument is not firmly secured, it could come off inside the body cavity during use and cause patient injury, such as mucous membrane damage.·if you encounter strong resistance when mounting the instrument on the endoscope, apply a water-soluble lubricant to the endoscope attachment section.¿ olympus will continue to monitor the field performance for this device.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: DISPOSABLE DISTAL ATTACHMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18435711
• Report Number: 9614641-2024-00010
• Device Sequence Number: 20591584
• Product Code: FDS
• UDI-Device Identifier: 04953170453878
• UDI-Public: 04953170453878
• 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): 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): 06/20/2024

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: D-201-12704
• Device Lot Number: 33K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 02/01/2024; 06/17/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/05/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PCF-H290I/UNKNOWN SERIAL NO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown