MAUDE Adverse Event Report: APPLIED MEDICAL CFS22, 12X100 KII SLEEVE ADVFIX 12/BX; GCJ

Model Number	CFS22
Medical Device Problem Codes	Detachment Of Device Component (1104); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) 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 or Problem Description
Laparoscopic procedure - "seal is falling off the cannula at minimal contact force.Loss of pneumoperitoneum." patient status - "ok.".
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Investigation summary: the incident product was not returned for evaluation, however a sample device from the same lot was returned.The sample device passed all leak testing and mechanical testing that was performed and engineering could not confirm the customer experience.A review of the manufacturing records for this lot confirmed that the product passed all manufacturing and quality inspections.During the manufacturing process, all kii advanced fixation trocars are thoroughly inspected and tested for functionality and performance prior to packaging.Although the root cause of the customer's experience could not be determined, applied medical 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: CFS22, 12X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5693050
• Report Number: 2027111-2016-00419
• Device Sequence Number: 16239445
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740(17)181105(30)01(10)1256753
• Combination Product (Y/N): N
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2016

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
• Operator of Device: Other
• Device Expiration Date: 11/05/2018
• Device Model Number: CFS22
• Device Catalogue Number: 101245301
• Device Lot Number: 1256753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 07/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1