MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE RETRIEVAL NITINOL BASKET V; SINGLE USE RETRIEVAL BASKET

Model Number	FG-V451P
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that during a stone quarrying case, the basket wire of the fg-v451p (subject device) got caught in the forceps elevator of the tjf-260v scope, making it impossible to remove the forceps or lower the forceps elevator.When the physician pulled out the scope, while the forceps elevator was still raised, the patient's stomach was lacerated and bleeding occurred.Hemostasis was applied, using a clip, to the part where the laceration occurred.The reporter stated that the patient did not receive a blood transfusion.Additional information has been requested regarding the reported event, including the current status of the patient.This report is being submitted for the fg-v451p (single use retrieval nitinol basket v), under the medwatch with patient identifier (b)(6).The tjf-260v (evis lucera duodenovideoscope) is being submitted under the medwatch with patient identifier (b)(6).
Additional Manufacturer Narrative
The subject device has not been returned to olympus for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being updated to report additional information provided by the customer.
Event or Problem Description
Update: additional information received from the customer: the patient's condition is unknown.The stone could not be removed by using the actual item.It occurred before the stone was removed.The size of the stone is unknown.It is unknown what caused the basket to get stuck.It is believed the position to open may have been too closed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, tissue damage may have occurred because the basket was removed while it was open.The basket likely got caught on the forceps raising table because the grasping part was operated while the endoscope raising table was up.The basket likely got caught on the hoist stand, causing the basket and hoist stand to become stuck.However, since the device was not returned to olympus for an evaluation, 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: ¿repetition of stone retrieval will deform and/or deteriorate this instrument.Deformation and/or deterioration may make it difficult to retrieve a stone or could cause the basket with stone engaged to become impacted in the body.If stone retrieval needs to be repeated in a single case, be sure to inspect the action and the appearance before each retrieval.Stop use if any abnormality (e.G., basket wire is cut or sheath is bent, etc.) is detected during the inspection.¿.¿if resistance is too strong and withdrawal is difficult, adjust the angle of the endoscope until the instrument can be withdrawn smoothly and withdraw the instrument from the endoscope if the basket is closed.Forcible withdrawal could damage the instrument or endoscope.¿.¿do not withdraw the instrument from the endoscope if the forceps elevator is up.This could damage the instrument.Withdrawing the instrument from the endoscope.Confirm that the forceps elevator of the endoscope is down.Pull the control grip to close the basket.Withdraw the instrument from the endoscope.This supplemental report includes a correction to g2 to provide information that was inadvertently not included on the initial medwatch.Also, new information has been added to d8.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE RETRIEVAL NITINOL BASKET V
• Common Device Name: SINGLE USE RETRIEVAL BASKET
• 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: 15974458
• Report Number: 9614641-2022-00762
• Device Sequence Number: 5883745
• Product Code: LQR
• UDI-Device Identifier: 14953170395328
• UDI-Public: 04953170395321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2023

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: FG-V451P
• Device Lot Number: N/A
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 04/18/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 12/16/2022; 05/08/2023
• 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: TJF-260V EVIS LUCERA DUODENOVIDEOSCOPE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female