MAUDE Adverse Event Report: WILSON-COOK MEDICAL, INC. HPC-3 HUBREGTSE TRIPLE LUMEN NEEDLE KNIFE; ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY

Model Number	G24885
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician was using hpc-3 huibregtse triple lumen needle knife during a procedure.The needle knife dropped off and fell into the pt.Physician visualized it and was able to remove it using forceps through the egd scope.No pt injury or extra procedure or recovery time needed.Fda safety report id# (b)(4).

• Brand Name: HPC-3 HUBREGTSE TRIPLE LUMEN NEEDLE KNIFE
• Common Device Name: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
• Manufacturer (Section D): WILSON-COOK MEDICAL, INC. ; winston-salem NC 27105
• MDR Report Key: 9734016
• Report Number: MW5093151
• Device Sequence Number: 2830243
• Product Code: ODD
• UDI-Device Identifier: 00827002248854
• UDI-Public: (01)00827002248854(17)220418(10)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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: 04/18/2022
• Device Model Number: G24885
• Device Catalogue Number: HPC-3
• Device Lot Number: W4205339
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR