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	05/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a cap was lost in the patients esophagus during an endoscopic submucosal dissection (esd) gastroscopy.The cap was retrieved with a grasping forceps.The cap was found cut in two on one side after it was retrieved.There was no injury to the patient.
Event or Problem Description
It was reported, that the incident caused a 5 minute procedural delay.However, it was confirmed, that the procedure was completed with a similar device.Moreover, the medical opinion of the facility was that the issue potentially increased the risk of perforation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus and a tear was noted.However, no reportable device malfunctions were observed.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.The subject device was manufactured in november 2023.Based on the results of the investigation, the root cause of the reported event (device tear and falling off into patient¿s esophagus) could not be determined.The event can be detected/prevented, by following the instructions for use (ifu), which states: ¿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¿.This supplemental report includes information added to a2, a3 and b5 from the initial medwatch.Also, an update has been made to h3.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: 19577149
• Report Number: 9614641-2024-01299
• Device Sequence Number: 8524949
• Product Code: FDS
• UDI-Device Identifier: 04953170278280
• UDI-Public: 04953170278280
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 3YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 08/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male