MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS 22G CELIAC PLEXUS NEEDLE; NEUROLYSIS NEEDLE

Model Number GF-UC140P-AL5

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/15/2020

Event Type  malfunction  

Event Description

During an outpatient eus with celiac plexus neurolysis procedure, the 22 g celiac plexus needle was advanced into the eus scope.When the scope exited the patient¿s mouth, the needle appeared to be extruded from the sheath of the scope.Am egd was performed immediately to asses for suspicious damage from the needle.Superficial tissue bleeding was noted in the stomach and esophagus.A chest xray will be completed post procedure.The patient was intubated under general anesthesia during this incident.Fda safety report id # (b)(4).

• Brand Name: 22G CELIAC PLEXUS NEEDLE
• Type of Device: NEUROLYSIS NEEDLE
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 9632142
• MDR Text Key: 176685189
• Report Number: MW5092502
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2020

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
• Device Operator: No Information
• Device Model Number: GF-UC140P-AL5
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR