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	04/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 establishment name: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, during the diagnostic surgery the disposable distal attachment broke and fell into the patient's stomach.The fallen piece was recovered by endoscopic method and took a few minutes.There was no effect on the patient or procedure outcome.The diagnosis and treatment outcome were not affected.The device was inspected before use with no abnormality.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to field (h3) and to provide additional information received through follow up (b5).The device was evaluated by olympus, and no abnormalities were observed.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 the following mechanisms could have caused the reported event.1) insufficient wiping of foreign material such as lubricant caused the foreign material to remain on the endoscope tip.2) the subject device was attached to the endoscope tip and secured with medical tape.3) the medical tape came off the endoscope due to the foreign material remaining on the endoscope tip.4) medical tape was not sufficiently secured.Therefore, it is possible that when a mechanical load was applied to the subject device during the procedure, the, the subject device detached from the endoscope tip and fell off into body.However, the root cause of the reported event could not be identified.The event can be prevented by following the instructions for use which state: "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 field performance for this device.
Event or Problem Description
Additional information obtained: it was reported that there have been no malfunctions in the most recent use, and the doctor on the scene believes that there was something wrong with the way the scope was used.(for example, the endoscopist said that the tape was not wrapped properly when attaching the scope.) furthermore, olympus was able to confirm that the distal attachment cap was fixed with medical tape.It seems that in the past it was not fixed, but it has been fixed recently.Additionally, it was reported that wiping off after using lubricants etc.Is probably not a problem, but some endoscopists have commented that the tape is not being applied properly (e.G., the tape is not sticking properly).

• 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: 19188390
• Report Number: 9614641-2024-00991
• Device Sequence Number: 7640795
• Product Code: FDS
• UDI-Device Identifier: 04953170453854
• UDI-Public: 04953170453854
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: GASTROSCOPE (GIF-Q260J)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown