MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; GCJ

Model Number	CTF01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2016
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
Laparoscopic cholecystectomy - "during re-insertion (port had previously slipped out) of the 5mm trocar into the patient, the shaft of the trocar cannula and obturator began to bend.The trocar was then replaced for another ctf01.However, mistakenly the surgeon placed the ctf01 obturator through a ctf12 cannula.When inserting this trocar through the existing defect the tip of the obturator snapped off and remained between the abdominal layers.The obturator tip (along with several pieces) were retrieved from the patient.In the same case 1x ctf73' & 2x cts22's were not allowing gas to be expelled through the insufflation port of the trocar in order to desufflate the patient.The staff could not be sure whether the fault was with the trocar, insufflation system or to do with patient positioning (as the patient was high bmi).The hospital are now in process of testing their insufflation system." patient status: "no patient injury".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation along with the broken obturator tip and clear fragments.Engineering confirmed the customer's experience of the obturator tip breaking off.Engineering reassembled the clear fragments with the obturator and obturator tip and noted that there were no missing pieces.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of the event is likely due to user error.As stated in the instructions for use (ifu), "kii access system cannulas can only be used with the corresponding kii obturators (diameter and length) from applied medical." 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.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 a supplemental report will be submitted to the fda.

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6070319
• Report Number: 2027111-2016-00744
• Device Sequence Number: 13537974
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)180528(30)01(10)1247406
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K041795
• 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): 12/28/2016

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: 05/28/2018
• Device Model Number: CTF01
• Device Catalogue Number: 101412701
• Device Lot Number: 1247406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2016
• Supplement Report FDA Received Date: 12/28/2016
• Patient Sequence Number: 1