MAUDE Adverse Event Report: APPLIED MEDICAL KII 12X100 FIOS Z-THREADED; LAPAROSCOPIC TROCAR, CODE:GCJ

Model Number CTF73

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/21/2013

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records for this lot reveals the lot passed all manufacturing and quality inspections.Although the root cause of your experience could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This document represents our final report.

Event Description

"cap of trocar fell off of trocar multiple times during the surgical procedure.The device was taken off sterile field equipment malfunction led to a loss of pneumoperitoneum which prevented visualization of patient anatomy." patient status - "care was not affected.".

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: KII 12X100 FIOS Z-THREADED
• Type of Device: LAPAROSCOPIC TROCAR, CODE:GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 949713-667
• MDR Report Key: 3757150
• MDR Text Key: 12114455
• Report Number: 2027111-2014-00202
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2014

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: Other
• Device Model Number: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1199992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/02/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1