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

Model Number	D-201-10704
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was informed of the customer's event via mw5107777.The customer reported, during an unknown procedure, the distal attachment attached to the endoscope was seen in the patient's stomach.It was retrieved with a roth net.The distal attachment was inspected prior to use and no issues were found.The distal attachment was inspected after removal from the patient and found to be cut in half.A request for additional information is in progress.Update: this event includes 2 complaints: (b)(6) - distal cap; (b)(6) - unknown egd scope.This is report 1 of 2 for (b)(6) - distal cap.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2951238-2022-00385.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer.New information added to b5.
Event or Problem Description
Additional information was requested from the customer.The customer confirmed the correct model number for the endoscope was provided.The customer did not clarify how the devices were attached to each other.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer.
Event or Problem Description
Additional information received from the customer: the procedure being performed was a therapeutic esophagogastroduodenoscopy to remove a food bolus.The intended procedure was completed however it is unknown if it was completed using the same device or a similar device.The customer reported no known procedural delay.The customer is unaware of any post-operative patient issues due to this malfunction.There was not any change in the patient's post-operative treatment course due to this issue.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.H4: sep2021.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the subject device detaching from the distal end of the endoscope due to the following reason: the subject device was attached to the endoscope gif h190n.However, gif h190n was not a compatible endoscope.In addition, the outer diameter of the distal end of the gif h190n is very narrower than the inner diameter of this product.Therefore, the connection between the subject device and the endoscope was possibly loose.This instruction manual contains the following information.(drawing no.Gk7705, revision no.10).Use this instrument only in combination with products recommended by olympus.If combined with products not recommended by olympus, patient or operator injury, malfunction or equipment damage may result.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on a the legal manufacturer's final investigation.Based on the investigation result (labeling review) and previous investigation results, it can be determined that the subject device was likely not secured in place by using a medical tape.This likely caused the subject device to fall off and inside the patient¿s body.The condition of the subject device could not be confirmed.Therefore, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿an endoscope with an observed irregularity should not be used, but should be inspected by following, ¿troubleshooting guide.¿ if the irregularity is still observed after inspection, contact olympus.¿ ¿before use, prepare and inspect the instrument as instructed below.Should any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, such as an infection control risk, tissue irritation, punctures, hemorrhages, or mucous membrane damage, which may result in more-severe equipment damage.¿ ¿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 a correction to h6 (investigation conclusion).Code corrected from ¿18 ¿ failure to follow instruction,¿ to ¿4315- cause not established.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 14189315
• Report Number: 8010047-2022-06887
• Device Sequence Number: 4481391
• Product Code: FDS
• UDI-Device Identifier: 04953170278266
• UDI-Public: 04953170278266
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/03/2024

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-201-10704
• Device Lot Number: 19K
• 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: 03/25/2022
• Supplement Date Received by Manufacturer: 04/25/2022; 06/17/2022; 08/29/2022; 01/06/2023; 05/03/2024
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/25/2022; 07/15/2022; 09/19/2022; 01/19/2023; 05/03/2024
• 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: GIF-H190, SERIAL (B)(6).; UNKNOWN OLYMPUS ENDOSCOPE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White