MAUDE Adverse Event Report: ETHICON ENDO SURGERY ENDOPATH; BLADELESS TROCAR

Lot Number M4HROL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/27/2015

Event Type  malfunction  

Event Description

Robotic laparoscopic tah/bso.Stability sleeve and working port cb12lt with v-loc and ct-1 needles used and passed through it.Needle and vicryl successfully passed through port and then a baby lap size 4x18 was then passed through port under direct vision and portion of diaphragm from trocar fell into the patient's abdominal cavity.Immediately and successfully retrieved parts.Per operating room director, this is the second incident where a ethicon trocar diaphragm became dislodged.Reference mw5057805.

• Brand Name: ENDOPATH
• Type of Device: BLADELESS TROCAR
• Manufacturer (Section D): ETHICON ENDO SURGERY; guaynabo PR 00969
• MDR Report Key: 5220493
• MDR Text Key: 31116671
• Report Number: MW5057804
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/06/2015

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 Expiration Date: 05/31/2015
• Device Lot Number: M4HROL
• Other Device ID Number: (01)10705036014218
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1