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

Model Number	CFS22
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	01/29/2017
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.
Event or Problem Description
Appemdectomy - es wurde ein 10mm metalltrokar eingeführt.Diese inzision wurde auf 12mm erweitert und dann eine 12er kii hülse von uns über einen taststab eingebracht.Dabei ist das untere teil der hülse unter dem ballon gebrochen.Ein stück wurde gefunden, das 2.Stück, ca.0,5 cm x 0,5 cm verblieb nach 1,5 stündigen erfolglosen suche ggf.In der patientin.Danach wurden die hülsen kontrolliert und auch da zerbrach bei geringem druck das untere teil unter dem ballon.Der kunde bittet um bericht.Translation (b)(6): the procedure began with a 10mm metallic reusable trocar.They increased the incision to 12mm.With a 10mm full metal rod the 12mm cannula was inserted into the incision.In this moment the distal part of cannula, below the balloon, was broken.One piece was found, but the second one they cannot found after 1,5 hour of searching in the patient.Maybe the not found a piece of 0,5 x 0,5 cm.After the issue, they tested the distal part of cannula.It was broken between thumb and index finger.The customer is asking for a direct full report.Additional info received via phone call from an applied medical sales representative on februay 1, 2017: the piece is left inside of the patient, size is unclear.Additional info received via email from an applied medical sales representative on february 1, 2017: they kept the broken sample of issue.Patient status: "alive.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with three unused units and a clear fragment.Upon inspection of the event unit, engineering was able to confirm the complainant's experience of cannula tip fracture.The clear fragment did not complete the cannula tip on the event unit when reassembled.Two of the three unused units had cannula tip fractures and the remaining unused unit met current specifications additional information was requested from the complainant regarding the quantity of units that were broken by the complainant, but the complainant was unable confirm the quantity.The likely root cause of the cannula tip fracture on the event unit is due to force applied on the trocar in combination with lipid exposure.The likely root cause of the cannula tip fractures for the two unused units is intentional force applied to the units by the complainant.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.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.
Event or Problem Description
Additional information received via email at 12:49 am on may 09, 2017 from team member: she doesn't remember how many trocars were broken between her fingers.

• 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: 6360906
• Report Number: 2027111-2017-01347
• Device Sequence Number: 16359073
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740(17)190411(30)01(10)1268789
• 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): 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/11/2019
• Device Model Number: CFS22
• Device Catalogue Number: 101245301
• Device Lot Number: 1268789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other