MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF74, KII 12X100 FIOS Z-THR HN 6/BX; GCJ

Model Number	CTF74
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2016
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.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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Report from sales representative (who was not present at the case): unknown procedure - (quoting the doctor day after event) "the patient was young slender male.Very tight abdomen.I didn't make my incision large enough.I went in at angle.I removed the trocar and noticed the tip was bent, not broken.I tried to see if it would straighten out with my fingers.It broke off at that time." product was ctf74.No patient injury.Used another ctf 74 that worked fine after enlarging the entry site.Site was left lower quadrant approx.3 to 4 inches from umbilicus.Additional information received via email from sales representative on november 7, 2016: it was just the obturator tip that bent.Not the cannula.
Additional Manufacturer Narrative
The event product was returned for evaluation.Engineering was able to confirm the complainant's experience of obturator tip damage.The customer stated that the obturator tip broke after attempting to straighten the bent obturator tip during the procedure.Based on similar experiences and the information provided by the customer, it is likely that the obturator tip damage was caused by the high insertion force applied to the trocar due to the small incision and angled trocar insertion.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: CTF74, KII 12X100 FIOS Z-THR HN 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6108137
• Report Number: 2027111-2016-00815
• Device Sequence Number: 10938771
• Product Code: GCJ
• UDI-Device Identifier: 00607915123710
• UDI-Public: (01)00607915123710(17)190713(30)01(10)1274194
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/18/2017

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: 07/13/2019
• Device Model Number: CTF74
• Device Catalogue Number: 101470925
• Device Lot Number: 1274194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1