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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found there was no buckling in the insertion part and the basket could be opened and closed with no problems.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the single use retrieval nitinol basket v got caught on the forceps elevator.The open basket was not passed through the forceps elevator and the basket center wire was not stored in the sheath.The issue was found during a therapeutic endoscopic retrograde cholangiopancreatography procedure and the procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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, the root cause of the basket center wire not stored in sheath, was due to excessively angulation.The center wire was not pulled in and that the basket could not be closed.The sheath near the support wire (form of a loop) was excessively angulated.The support wire which protruded from the coil sheath was excessively angulated.The event can be prevented by following the instructions for use which state: ¿·never use excessive force to operate the instrument.This could damage the instrument.·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.·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.·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 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.¿ 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: 16132157
• Report Number: 9614641-2023-00028
• Device Sequence Number: 14262606
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: 19K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2021
• 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
• Patient Sex: Unknown