MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ECHOTIP ULTRA FIDUCIAL NEEDLE; FCG, BIOPSY NEEDLE KIT

Model Number	G03793
Medical Device Problem Codes	Break (1069); Component Missing (2306); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
During an unspecified procedure, the physician used a cook echotip ultra fiducial needle.It was initially reported that there were no fiducials on the needle.There was no reportable information at this time.It was determined on 18 october 2022 per device evaluation that the needle had the correct number (4) of fiducials; however, they were unable to retract needle (subject of this report).A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The correct number (4) of fiducials were inside the needle.The needle was returned extended from the sheath and the thumb screw on the sheath adjustment was missing and not included with the returned device.The handle was in the retracted position.The handle was manipulated and the needle did not advance or retract.The handle provided no resistance and the needle did not seem to be moving inside the sheath or the handle.The handle was disassembled for further evaluation, and it was confirmed that the needle had separated from the inner cannula.The needle was removed from the device and examined at the attachment point with the inner cannula.There did appear to be glue on the proximal end of the needle between the marked areas.A lab meeting was held with quality engineering, production leadership from metals, and manufacturing engineering.Evidence of sufficient glue was found to be on the luer threads when unscrewing the handle and on the needle where it is inserted into the handle cannula, confirming the needle and handle were assembled correctly during the manufacturing process.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record does contain a nonconformance that could potentially be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Investigation conclusion: our laboratory evaluation confirmed the report of needle unable to retract due to the needle breaking and detaching at the handle end.A root cause was not able to be determined for the breakage and detachment.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Prior to distribution, all echotip ultra fiducial needles are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Common Device Name: FCG, BIOPSY NEEDLE KIT
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 15744862
• Report Number: 1037905-2022-00614
• Device Sequence Number: 5402596
• Product Code: FCG
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)230505(10)W4593308
• Combination Product (Y/N): N
• PMA/510(K) Number: K141356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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 Expiration Date: 05/05/2023
• Device Model Number: G03793
• Device Catalogue Number: ECHO-22-F
• Device Lot Number: W4593308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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: PENTAX SCOPE UNKNOWN MODEL
• Patient Sex: Unknown