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

Model Number	D-201-11804
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the disposable distal attachment, during the esophagogastroduodenoscopy (egd), the disposable distal attachment came off the gastroscope into the patient's oral cavity and pharynx and had to be retrieved.There was a delay in the procedure (amount of time not specified).The procedure was completed and there was no patient harm.This report is related to and linked patient identifier (b)(6).
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing [and follow up with the user facility is currently being performed].A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot/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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use: ¿·use this instrument only in combination with products recommended by olympus.If combined with products not recommended by olympus, the instrument may fall off of the endoscope inside the patient and may cause malfunction or equipment damage.·if you encounter strong resistance when mounting the instrument on the endoscope, apply a water-soluble lubricant to the endoscope attachment section.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.¿ 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: 18565150
• Report Number: 9614641-2024-00151
• Device Sequence Number: 6858227
• Product Code: FDS
• UDI-Device Identifier: 04953170278280
• UDI-Public: 04953170278280
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: D-201-11804
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 77 YR
• Patient Sex: Unknown
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White