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

Catalog Number CTF73

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

Event Type  Injury  

Event Description

During robotic case, the plastic piece of the trocar fell off before reaching the patient.Fda safety report id# (b)(4).

• Brand Name: 12 MM TROCAR
• Type of Device: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP.
• MDR Report Key: 10605915
• MDR Text Key: 209453317
• Report Number: MW5096952
• Device Sequence Number: 1
• Product Code: GCP
• 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: 1384276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 56 YR
• Patient Weight: 142