MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP. TROCAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	CTF73
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During robotic prostatectomy, part of the black rubber piece of the 12x100mm trocar broke off into the patient.It was noticed on the camera by the scrub tech.The piece was retrieved, and the packaging to the trocar returned to materials.All pieces accounted for.Fda safety report id # (b)(4).

• Brand Name: TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP.; rancho santa margarita CA 92688
• MDR Report Key: 13499735
• Report Number: MW5107308
• Device Sequence Number: 4682507
• Product Code: GCJ
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

1 Device was Involved in the Event

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
• Device Catalogue Number: CTF73
• Device Lot Number: 1427908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2022
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Hispanic
• Patient Race: White