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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC ENDOPATH XCEL LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
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.

 
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Brand NameENDOPATH XCEL
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
4545 creek rd.
cincinnati OH 45242
MDR Report Key8887471
MDR Text Key154116708
Report Number8887471
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberB15LT
Device Catalogue NumberB15LT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2019
Device Age0 yr
Event Location Hospital
Date Report TO Manufacturer08/13/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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