MAUDE Adverse Event Report: ETHICON ENDOSURGERY, LLC ENDOPATH EXCEL BLUNT TIP TROCAR WITH SMOOTH SLEEVE

Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Malfunction of the endopath xcel blunt tip trochar suture tie post in that the post was dislocated from the device and unable to be retrieved from the patient, and a second endopath xcel blunt tip trochar was used and the post from the 2nd device was dislodged as well, but was retrieved prior to entering the patient.The first trochar was in the flextray procedure delivery system.The second trochar was separate.

• Brand Name: ENDOPATH EXCEL BLUNT TIP TROCAR WITH SMOOTH SLEEVE
• Common Device Name: BLUNT TIP TROCAR
• Manufacturer (Section D): ETHICON ENDOSURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 6629602
• Report Number: MW5070263
• Device Sequence Number: 734680
• Product Code: GCJ
• UDI-Device Identifier: 10705036007586
• UDI-Public: (01)10705036007586(17)211231(10)P9162C
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 05/24/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 53 YR
• Patient Weight: 113