MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOPATH, ULTRA VERESS; INSUFFLATOR, LAPAROSCOPIC

Model Number	UV120
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Tried to insufflate during laparoscopic appendectomy, insufflation tubing was connected to veress needle which was in patient and monitor started flashing high numbers and said it was occluded.Took out of patient and looked at tubing and veress needle and noticed tip of veress needle was occluded and air was not able to pass through the hole at the end.Opened new veress needle to use during surgery and saved old one to be sent back to manufacturer.

• Brand Name: ENDOPATH, ULTRA VERESS
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 8435630
• Report Number: 8435630
• Device Sequence Number: 11275680
• Product Code: HIF
• UDI-Device Identifier: 10705036013426
• UDI-Public: (01)10705036013426
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2019
• Report Date (Section F): 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UV120
• Device Catalogue Number: UV120
• Device Lot Number: T40324
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/08/2019