MAUDE Adverse Event Report: APPLIED MEDICAL CTF73, 12X100 KII FIOS ZTHR 6/BX; GCJ

Model Number CTF73

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.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.

Event Description

Gastric bypass - "a piece of the trocar fell out of the trocar into the abdomen of the patient.It is the transparent piece that will direct the instrument in the right direction.The transparent piece also protects the from sharp instruments.The piece was seen and removed right away." patient status - "fine, the piece was coated right away, and removed.".

Manufacturer Narrative

Investigation summary: the event unit was returned along with two (2) sterile samples and a dislodged shied.Upon inspection of the event unit, engineering removed the seal and noted the seal components were present within the seal housing and no visible damage was observed.The unit met design specifications.Upon inspection of the dislodged shield, engineering found scratches were present on the outer perimeter of the distal end.During the manufacturing process all kii trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of this incident could not be determined as the returned units met design specifications.After review of customer experience reports from (b)(4), engineering identified a similar incident (mdr#2027111-2016-00085) in which the unit was found to be missing the plastic shield, and believes the shield returned under this incident actually corresponds to mdr#2027111-2016-00085.Applied medical contacted the customer for confirmation the dislodged shield actually corresponds with mdr#2027111-2016-00085, however, the customer was unable to confirm.Although the root cause of the experience could not be determined, applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: CTF73, 12X100 KII FIOS ZTHR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5437487
• MDR Text Key: 38228369
• Report Number: 2027111-2016-00125
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703(17)180907(30)01(10)1253959
• Combination Product (y/n): N
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

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: Other
• Device Expiration Date: 09/07/2018
• Device Model Number: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1253959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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