MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACUJECT VARIABLE INJECTION NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number	G22525
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A photo of a handwritten note was included, and the lot number on the note matches that in the report.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all adject variable injection needles are subjected to a functional test to ensure appropriate needle extension.A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.There have been no other reported occurrences similar in nature during the time period reviewed.Therefore, this represents an isolated occurrence.Based on this review, the likelihood of this type of report is remote.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During an endoscopic injection, the physician used a cook adject variable injection needle.When using the sclerosis needle, the user noticed great difficulty in testing its exposure [advancement].After several unsuccessful attempts, there was one with exposure beyond normal.When retracting the tip, the mandrel came loose from the catheter lumen, making it impossible to use [unable to inject].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 further adverse effects due to this occurrence.

• Brand Name: ACUJECT VARIABLE INJECTION NEEDLE
• Common Device Name: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; NC
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105
• MDR Report Key: 23597818
• Report Number: 1037905-2025-00789
• Device Sequence Number: 18714928
• Product Code: FBK
• UDI-Device Identifier: 00827002225251
• UDI-Public: (01)00827002225251(17)280130(10)W4909934
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K190829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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: G22525
• Device Catalogue Number: VIN-23
• Device Lot Number: W4909934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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 Age: 71 YR
• Patient Sex: Unknown