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 Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that, during a procedure, the retrieval basket could not be inserted into the endoscope.A second device was opened and stones were collected.When attempting to use the second device to retrieve additional stones, it did not unfold.The user attempted the first device again and was able to insert it in the endoscope but it also did not unfold.A third device was used to complete the procedure.The subject device was sent to olympus for evaluation.During inspection and testing, the basket could not be opened.This report is being submitted for the malfunction found during evaluation (unable to open basket).There was no effect on the patient due to the event.This report is for the first device.The second device is being reported on the medwatch with patient identifier (b)(6).
Additional Manufacturer Narrative
During inspection and testing, the knob could not be pushed and the basket could not be opened.When the tip of the basket was pinched and the coil sheath pulled out, foreign matter was attached.By cleaning the basket and removing the foreign material, the basket could be opened and closed.There was no conformity in the shape of the basket.There was no strong resistance when inserting the device into an endoscope.There was some resistance near the forceps riser when attempting to extend the device from the endoscope but the basket could be deployed and could be opened and closed.The report that the user could not be extended from the endoscope was not reproduced.A review of the device history record found no deviations that could have caused or contributed to the basket not opening.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the basket could not be opened due to foreign matter adhering to the basket wire which clogged the coil sheath and prevented the basket from opening.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warnings, which may help to prevent the issue: " check that no abnormality is detected in the action of the handle.If there is any abnormality, the stone may not be retrieved and/or the basket with stone engaged may become impacted in the body." "when inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the insertion portion could be damaged." "do not insert the instrument into the endoscope if the basket is not fully closed.Otherwise, patient injury, such as perforation, bleeding, or mucous membrane damage could occur.It could also damage the endoscope and/or instrument." "do not force the instrument if resistance to insertion is encountered.Reduce the endoscope's angulation or lower the forceps elevator of the endoscope until the instrument passes smoothly." "when the basket does not open and/or close smoothly, do not apply force but move the forceps elevator, set the endoscope's bending angle back, or move the position of the basket until the basket opens and closes smoothly.If the action of opening/closing the basket is forced, the sheath may stretch and the resistance in operating the handle may increase.Also, the stone may not be retrieved, and/or the basket with stone engaged may become impacted in the body." "do not open or close the basket while the forceps elevator of the endoscope is up.Otherwise, the support wire may form a loop.Do not withdraw the instrument from the bile duct while a loop is formed by the support wire.Otherwise, the looped distal end could damage the inside of the bile duct and cause mucosal injury.If a loop of support wire is observed, lower the forceps elevator and open/close the basket." "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." olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15375609
• Report Number: 9614641-2022-00276
• Device Sequence Number: 20282907
• Product Code: LQR
• UDI-Device Identifier: 04953170395321
• 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,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-V451P
• Device Lot Number: 02K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• 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: 02/09/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2020
• 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: JF-260V- OLYMPUS DUODENOVIDEOSCOPE
• Patient Sex: Unknown