MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP. APPLIED MEDICAL; TROCAR

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2015

Event Type  malfunction  

Event Description

A black circle was noticed in the surgical field and was removed by the assisting surgeon.The black piece matched the missing area from a trocar.All pieces are believed to have been removed from the pt.The trocar was removed and replaced.No pt harm.

• Brand Name: APPLIED MEDICAL
• Type of Device: TROCAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP.; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5249588
• MDR Text Key: 32212786
• Report Number: MW5058077
• 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: Other
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 109