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

Model Number	G22526
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	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During colon polyp removal, the physician used a cook acuject variable injection needle.It was reported that the physician advanced the needle into endoscope working channel to lesion area, the physician planned to inject but no response from needle tip.The handle had detached from the needle.[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 adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a white plastic bag.Provided with the return was 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 based on the condition of the device.The device was returned with the adjustment wheel threaded and the handle cannula unattached to the device.A visual examination of the device confirmed the handle cannula has separated from the inner sheath rendering the device inoperable.A close visual examination of the inner needle catheter components and handle cannula assembly was conducted.The handle cannula of this device is attached to the inner needle catheter with glue and a crimping process.Under magnification glue residue was observed in the appropriate area of the cannula.The band at the proximal end of the inner needle catheter also exhibits evidence of the crimping process and no cracks or split areas were observed in the band.Both manufacturing processes to connect the handle cannula to the inner needle catheter appear to have been completed as intended.It is unknown how the handle cannula became separated.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: our visual and functional evaluation of the returned device confirmed the report.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 acuject 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.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• 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 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 25678192
• Report Number: 1037905-2026-00308
• Device Sequence Number: 9709712
• Product Code: FBK
• UDI-Device Identifier: 00827002319035
• UDI-Public: (01)00827002319035(17)290120(10)W5001235
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K190829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: G22526
• Device Catalogue Number: VIN-25
• Device Lot Number: W4955219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENTAX COLONOSCOPE.
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 60 KG