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

Model Number	CFS22
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Myomectomy - "seal detaches very easily from cannula.During grasper use in the trocar (5mm reusable stroz grasper), seal detach from cannula.It detaches each time they raise grasper shaft from cannula.They reported it happened one time in the past (data not available, don't remember intervention/surgeon, no sample available).No any report to (b)(6).Sample available for inspection." patient status - "good, no any injury to the patient.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed the seal housing was easily dislodged from the cannula.During the manufacturing process, all trocars are thoroughly inspected and tested for functionality and performance prior to packaging.The root cause of this incident is likely due to an undersized tab distance of one of the two tabs that attach the seal housing to the cannula.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As part of this continuous process, applied medical is currently researching possible device enhancements intended to further minimize the potential for this type of incident to occur.We apologize for any inconvenience this may have caused and assure you that applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.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: 5683947
• Report Number: 2027111-2016-00415
• Device Sequence Number: 13506545
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740(17)181105(30)01(10)1256753
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/29/2016

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: 06/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2016
• Supplement Report FDA Received Date: 08/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1