MAUDE Adverse Event Report: AMR CFF74, 12X100 KII FIOS ADVFIX HDL 6/BX; GCJ

Model Number	CFF74
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2016
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
Appendicitis - "charge nurse stated that dr.(b)(6) had a difficulty advancing the 45mm stapler through the 12mm trocar, they heard a popping sound then the instrument was able to pass through the trocar, after the appendix was taken out, they gave patient the tracar and a small piece of plastic they thought was a part that broke off during the popping sound, after inspecting the trocar, the small black plastic was confirmed as a part of the trocar's air locking system and no other parts are missing from the trocar, surgeon and scrub tech also confirmed the piece and that no other parts are left inside the patient." patient status - good condition.
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Investigation summary: the event product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.The root cause might be instrument damage from the stapler as it passed through the trocar.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.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 additional information is obtained which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: CFF74, 12X100 KII FIOS ADVFIX HDL 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5720868
• Report Number: 2027111-2016-00442
• Device Sequence Number: 88276
• Product Code: GCJ
• UDI-Device Identifier: 00607915117665
• UDI-Public: (01)00607915117665(17)181230(30)01(10)1260812
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

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: 12/30/2018
• Device Model Number: CFF74
• Device Catalogue Number: 101450601
• Device Lot Number: 1260812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1