MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC ENDOPATH XCEL; TROCAR

Catalog Number CB12LT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

Surgical procedure laparoscopic robotic assisted hysterectomy, bilateral salpingo-oophorectomy.Md did abdominal cavity exmination before final closure of port sites.Plastic looking black washer type object was noticed in abdominal cavity.After inspection of all the items, it appears that inner washer of device dislodged and was placed into patient.

• Brand Name: ENDOPATH XCEL
• Type of Device: TROCAR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC; 4545 creek road,; cincinnati, OH 45242
• MDR Report Key: 4198675
• MDR Text Key: 4960994
• Report Number: 4198675
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2014

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: Physician
• Device Catalogue Number: CB12LT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PT IN ROBOTIC SURGERY