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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/22/2017

Event Type  Injury  

Event 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
• Type of Device: BLUNT TIP TROCAR
• Manufacturer (Section D): ETHICON ENDOSURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 6629602
• MDR Text Key: 77302570
• Report Number: MW5070263
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036007586
• UDI-Public: (01)10705036007586(17)211231(10)P9162C
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 53 YR
• Patient Weight: 113