MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENSEAL X1; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Model Number NSLX120L

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 04/26/2018

Event Type  malfunction  

Event Description

Jaw tissue sealer didn't work (ref # (b)(4) lot: p94d3c expiration: 10/31/2019).This disposable instrument was being used in an open belly case.The instrument was plugged into the machine.Instrument would not work.Machine alert was to re-angle jaw.This was done several times.The machine was restarted.The instrument would still not work.We opened another instrument and it worked with no issues.

• Brand Name: ENSEAL X1
• Type of Device: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 7534463
• MDR Text Key: 108929486
• Report Number: 7534463
• Device Sequence Number: 1
• Product Code: HGI
• UDI-Device Identifier: 10705036015024
• UDI-Public: (01)10705036015024
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: NSLX120L
• Device Catalogue Number: NSLX120L
• Device Lot Number: P94D3C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR