MAUDE Adverse Event Report: ETHICON ENDO SURGERY XCEL BLADELESS TROCAR W STABILITY SLEEVE B5LT

Model Number B5LT

Device Problem Break (1069)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 10/03/2022

Event Type  Injury  

Event Description

The patient was undergoing peritoneal dialysis catheter placement.The surgeon made the incision and placed a trocar in the incision site.The surgeon performed the assessment and removed the trocar.The physician noticed that the tip of the trocar was missing.The surgeon performed an ex-lap to locate the broken trocar tip.The surgeon explored the abdomen for about three hours before they located and removed the broken tip.The procedure was supposed to be an outpatient surgery that turned into a six day hospital admission.The patient was bloated and experienced nausea and vomiting while in the hospital.

• Brand Name: XCEL BLADELESS TROCAR W STABILITY SLEEVE B5LT
• Type of Device: TROCAR
• Manufacturer (Section D): ETHICON ENDO SURGERY
• MDR Report Key: 15668191
• MDR Text Key: 302397643
• Report Number: 15668191
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: B5LT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American