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

Model Number UV120

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2019

Event Type  malfunction  

Event 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
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 8435630
• MDR Text Key: 139313605
• Report Number: 8435630
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10705036013426
• UDI-Public: (01)10705036013426
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UV120
• Device Catalogue Number: UV120
• Device Lot Number: T40324
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1