MAUDE Adverse Event Report: STRYKER TROCAR XCEL DILATING TIP TROCAR W/STABILITY SLEEVE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number D12LT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/15/2022

Event Type  Injury  

Event Description

During laparoscopic appendectomy an unfamiliar object was noted on the screen.This was patients first surgical procedure.Provider notified and object was successfully retrieved from cavity and identified as a part of the trocar.Object is a soft plastic circular item with perforations around the edge.A wedge shaped piece appeared to be missing.Unable to locate.Fda safety report id# (b)(4).

• Brand Name: TROCAR XCEL DILATING TIP TROCAR W/STABILITY SLEEVE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER; tempe AZ 85283
• MDR Report Key: 15085959
• MDR Text Key: 296512144
• Report Number: MW5111067
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D12LT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Race: White