MAUDE Adverse Event Report: COOK ENDOSCOPY DISPOSABLE VARICES INJECTOR; FBK, ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Catalog Number	TDVI-25-240
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.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.The instructions for use state: "if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use also state to "disengage luer slip fitting from adjustment wheel prior to adjusting needle extension.Caution: attempting to adjust needle while luer slip fitting is engaged may result in damage to device." additionally, the instructions for use state to "verify adjustment by advancing and engaging luer slip fitting.Needle should move in and out of outer sheath easily.Inspect needle for breaks.Caution: advancing and retracting needle while catheter is coiled may result in stretching of catheter and damage to device." prior to distribution, all disposable varices injectors are subjected to a functional test to ensure appropriate needle extension.During packaging a visual inspection of the distal end of the sheath is conducted to insure the needle is not extending from the sheath.A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.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.
Event or Problem Description
During an endoscopic procedure, the physician used a cook disposable varices injector.The catheter separated [unknown location] and did not pull back into the needle correctly.It's unknown how the procedure was completed.

• Brand Name: DISPOSABLE VARICES INJECTOR
• Common Device Name: FBK, ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5700586
• Report Number: 1037905-2016-00167
• Device Sequence Number: 12682114
• Product Code: FBK
• UDI-Device Identifier: 00827002218598
• UDI-Public: (01)00827002218598(17)190309(10)W3693234
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K851952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2016

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 Catalogue Number: TDVI-25-240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2016
• Initial Report FDA Received Date: 06/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1