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

Model Number	D-201-11804
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	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifier: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-00235.
Event or Problem Description
It was reported, the disposable distal attachment (cap) fell off from the gastrointestinal videoscope and into the patient's stomach in the middle of a therapeutic esophagogastroduodenoscopy with food bolus disimpaction and was retrieved by the physician.The procedure and patient's anesthesia were prolonged for about 30 minutes and was completed with a different scope and cap.The patient was intubated prior to the procedure due to aspiration risk and was extubated the next day.Reportedly, the plan would most likely have been the same even if the cap had not fallen off due to the large amount of retained food.The customer confirmed that the condition of the patient and outcome of the procedure was not impacted.Both devices were inspected prior to use and the staff had made sure that the scope was compatible with the cap.The patient was discharged to home without any further harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received through follow up.The subject device was manufactured on december 2023 based on the provided 3 digit lot information "3zk".However, the exact manufacture date is unknown.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the reported event occurred due to the subject product was not secured to the endoscope by medical tape.However, the subject device was not returned, and the root cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: "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 xylocain 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." additional information received: it was reported that tape was not used to secure the subject device to the distal end of the endoscope.Additionally, the subject device was mounted on the endoscope before lubricant was applied.Olympus will continue to monitor 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: 19249349
• Report Number: 9614641-2024-01036
• Device Sequence Number: 15100581
• Product Code: FDS
• UDI-Device Identifier: 04953170453854
• UDI-Public: 04953170453854
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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-201-11804
• Device Lot Number: 3ZK
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 12/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GASTROINTESTINAL VIDEOSCOPE (GIF-HQ190/2167610)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White