MAUDE Adverse Event Report: ETHICON ENDO-SURGERY COMPANY ENDOPATH XCEL BLUNT TIP TROCAR 12MM

Model Number H12LP

Device Problems Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/04/2016

Event Type  Injury  

Event Description

Ethicon endo surgery co.Endopath xcel blunt tip trocar 12mm, piece of plastic broke off and were not able to find.Possibly in patient.Physician performing abd surgery.Trocar came apart and small plastic piece came off.Unable to find on field, in drapes, x-ray performed but piece not radiopaque so inconclusive.

• Brand Name: ENDOPATH XCEL BLUNT TIP TROCAR 12MM
• Type of Device: TROCAR
• Manufacturer (Section D): ETHICON ENDO-SURGERY COMPANY
• MDR Report Key: 6043147
• MDR Text Key: 58075879
• Report Number: MW5065511
• Device Sequence Number: 1
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H12LP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other