MAUDE Adverse Event Report: APPLIED MEDICAL KII-CTF73 TROCAR

Lot Number 1257030

Device Problems Loss of or Failure to Bond (1068); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2016

Event Type  malfunction  

Event Description

During laparoscopic appendectomy, physician requested that the trocar be sent back to the manufacturer.Seal would not seal allowing co2 to escape and caused delay in procedure.Trocar and label secured's in biohazard bag.

• Brand Name: KII-CTF73 TROCAR
• Type of Device: KII-CTF73 TROCAR
• Manufacturer (Section D): APPLIED MEDICAL; rancho santa margarita CA 92688
• MDR Report Key: 5694267
• MDR Text Key: 46494584
• Report Number: MW5062585
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2016

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
• Device Operator: Health Professional
• Device Lot Number: 1257030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 57