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

Model Number B15LT

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2019

Event Type  malfunction  

Event Description

Staff report: "grey plastic flap that is attached to the opening of the 15mm xcel bladeless trocar broke off inside the patients abdomen during robotic surgery.Dr.Noticed grey plastic piece in patient's abdomen.Upon inspection the grey flap that covers the opening of the port was broken on the inside xcel trocar." device was brought to clinical engineering for evaluation.On the opening of the trocar port there are flaps that cover the hole when the instrument is removed.It appears one of the flaps tore off and fell into the patient.The piece retrieved from the patient matches the part missing from the device and it does not look like there are more missing fragments.The flaps are made from a thin rubber-like material.It is possible the piece was caught on an instrument or the trocar and torn off.Original packaging was not saved so lot number is unknown.

• Brand Name: ENDOPATH XCEL
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 8887471
• MDR Text Key: 154116708
• Report Number: 8887471
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2019

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: Health Professional
• Device Model Number: B15LT
• Device Catalogue Number: B15LT
• 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: 07/24/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA