MAUDE Adverse Event Report: AMR CFS02, 5X100 KII SLEEVE ADVFIX 12/BX; GCJ

Model Number	CFS02
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2016
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
"this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation." report from the sales rep - the protective cap was not removed from cannula during pre-use check before procedure.Initial investigation report by (b)(4) olympus -the actual event unit was returned to olympus and visually inspected.Confirmed the cap was between balloon and disk.The event unit will be returned to applied medical for further evaluation.Please analyze this complaint phenomenon and review the device history record of the event unit.(b)(4) patient status: "no patient injury".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed the tip protector was located on the proximal side of the trocar behind the balloon.Engineering noted no visible damage on the trocar sleeve or the balloon.All advanced fixation trocars are packaged so that the retention disc prevents any sleeve protector movement in the proximal direction.The inner diameter of the tip protector was found to be within specification.The retention disk was found to be oversized; however, this could be due to the retention disc form-fitting to the size of the cannula as it was returned to applied medical with the disc pushed towards the wider portion of the cannula.Based on the event description, the retention disc and sleeve protector were likely moved by the customer when opening and inspecting the unit.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 with 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: CFS02, 5X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5763292
• Report Number: 2027111-2016-00489
• Device Sequence Number: 998
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)181210(30)01(10)1261187
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2016

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: 12/10/2018
• Device Model Number: CFS02
• Device Catalogue Number: 101411201
• Device Lot Number: 1261187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1