MAUDE Adverse Event Report: APPLIED MEDICAL KII OPTICAL ACCESS SYSTEM; TROCAR

Lot Number 1307303

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2017

Event Type  Injury  

Event Description

Applied medical kii optical access system: trocar was inserted into patient.Surgeon was using ligaclip appliers and seal of trocar broke off into patient's abdomen.Surgeon retrieved the seal.No adverse impact to the patient.Diagnosis or reason for use: surgery.Event avated after use stopped or dose reduced: yes.

• Brand Name: KII OPTICAL ACCESS SYSTEM
• Type of Device: TROCAR
• Manufacturer (Section D): APPLIED MEDICAL; rancho santa margarita CA 92688
• MDR Report Key: 7128550
• MDR Text Key: 95379793
• Report Number: MW5074110
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Lot Number: 1307303
• Was Device Available for Evaluation?: Yes
• 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: 45 YR
• Patient Weight: 115