MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOPATH XCEL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number B15LT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Date 01/20/2020

Event Type  malfunction  

Event Description

The surgeon had just stapled and divided the bronchus.At this point, a small piece of plastic was noted within the chest.This was placed into a glove tip and removed through the assistant port.It appeared that there was a piece of plastic at the entry point that was damaged.It appeared that there were a total of 4 leaflets at the entry point to the assistant port.Two were intact.One was removed from the chest previously.He examined the right chest and identified the fourth leaflet.A new assistant port was then placed.He examined the chest and found no other foreign bodies.The patient was successfully extubated and transferred to the recovery room in good condition.

• Brand Name: ENDOPATH XCEL
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 9732354
• MDR Text Key: 180148529
• Report Number: 9732354
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: B15LT
• Device Catalogue Number: B15LT
• Device Lot Number: L-007273-12868
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA