MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP. 12 MM TROCAR; TROCAR ENDOSCOPE AND ACCESSORIES

Catalog Number CTF73

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2020

Event Type  Injury  

Event Description

During a robot-assisted laparoscopic prostatectomy, the 12mm disposable trocar lost inner clear plastic ring during surgery.First assistant and surgeon saw it laying inside abdomen during robotic procedure and removed the plastic clear ring from abdominal cavity.(item is not radiopaque and not normally visualized on a trocar to be able to confirm it is intact.) fda safety report id# (b)(4).

• Brand Name: 12 MM TROCAR
• Type of Device: TROCAR ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP.
• MDR Report Key: 10605905
• MDR Text Key: 209456337
• Report Number: MW5096951
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CTF73
• Device Lot Number: 103954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 96