MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES 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	05/11/2016
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 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
Lap.Sigmaresection - "disconnection / detachment of the seal (seal - cannula) during instrument-change".Patient status - "ok".
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Investigation summary: the complete incident products were not returned for evaluation; however two seal housing units were returned.Upon visual inspection of the two seal housing units, engineering found no signs of physical damage.Engineering tested the returned seal housing units by connecting them to sample cannulas of the same part number as the event cannula.The seal housing did not dislodge from the cannula when a pull-test was performed and engineering was unable to confirm the customer's experience.In the absence of the complete subject devices, it is difficult to determine the root cause of the incident.The remaining two products that were reported in this case were not returned for evaluation.In the absence of the subject devices, it is difficult to determine the root cause of the incident.All trocars are thoroughly inspected during the manufacturing process and a review of the manufacturing records indicates the lots associated with this event passed all manufacturing and quality inspections.Although the exact root cause of the incident could not be confirmed, the likely root cause may be due to the cannula latch tabs being undersized.Applied medical is researching process enhancements intended to minimize the potential for this type of incident to occur.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.Reference mdr: 2027111-2016-00447, 2027111-2016-00448, 2027111-2016-00449, 2027111-2016-00451.

• Brand Name: CFS22, 12X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5707659
• Report Number: 2027111-2016-00448
• Device Sequence Number: 18888452
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740(17)181130(30)01(10)1258214
• 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): 05/12/2016

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: 11/30/2018
• Device Model Number: CFS22
• Device Catalogue Number: 101245301
• Device Lot Number: 1258214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2016
• Supplement Report FDA Received Date: 10/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1