MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8701, S ALEXIS LAP SYS W/ KII FIOS; GCJ

Model Number	C8701
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed : unknown event description: "noticed that a piece of cannula was broken off but was able to retrieve from the patient's abdomen.The patient was of large size, and a lot of torque was needed for the laparoscopic instruments when the cannula cleanly broke." additional information was received health systems manager via email on thursday, september 21, 2017: "a piece of the tip broke off.I am still attempting to find out if this was while inserted within the alexis lap cap or within the patient's abdomen.I am attempting to find out what instrument was inserted through the trocar when it experiences a break." type of intervention: "unknown." patient status: "no patient injury.".
Additional Manufacturer Narrative
The trocar from the event unit was returned to applied medical for evaluation along with three sterile units.Visual inspection of the trocar from the event unit confirmed the complainant's experience of a fractured cannula.The complainant did not allege any malfunction with the three sterile units.Based on the condition of the returned unit and the event of the description, it is likely that the reported event was caused by an outward force exerted on the cannula tip during instrument removal.The probability and criticality of harm resulting from this failure 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.

• Brand Name: C8701, S ALEXIS LAP SYS W/ KII FIOS
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6930958
• Report Number: 2027111-2017-02023
• Device Sequence Number: 461885
• Product Code: GCJ
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)200503(30)01(10)1296300
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• 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): 11/10/2017

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: 05/03/2020
• Device Model Number: C8701
• Device Catalogue Number: 101135801
• Device Lot Number: 1296300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1