MAUDE Adverse Event Report: APPLIED MEDICAL CTS02, 5X100 KII SLEEVE ZTHR 12/BX; GCJ

Model Number CTS02

Device Problem Component Missing (2306)

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

Event Date 11/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident device is anticipated to return.A follow-up report will be provided upon completion of the 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

Laparoscopic hernia case - " a laparoscopic tacker device was used to secure the hernia mesh to the abdominal wall during the procedure.After removing the trocar the surgeon noticed that the tip of the cannula was missing a few pieces.They then removed the pieces from inside the abdominal cavity." intervention - "na." patient status - "fine".

Manufacturer Narrative

Investigation summary: we have tried to obtain the incident device for evaluation with no success.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.Although the exact root cause of the incident could not be determined, applied medical has received reports of similar issues and has opened a corrective and preventative action report to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of incident.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.Additional information was requested from the customer and provided.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: CTS02, 5X100 KII SLEEVE ZTHR 12/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: loananh nguyen ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5333694
• MDR Text Key: 35068039
• Report Number: 2027111-2015-00929
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/12/2018
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1246854
• Other Device ID Number: 00607915123499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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