MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF12, 5X100 KII FIOS ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF12
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a bent trocar.The obturator was also cracked and fractured.Based on the condition of the returned unit and event description, it is likely that the bent cannula was caused by a high insertion force that was applied to the trocar during insertion, which could be attributed to the high bmi and tough peritoneum of the patient.It is possible that the obturator cracked and fractured due to a material abnormality or prolonged lipid exposure while the unit was in transit; however, the exact root cause could not be determined.The probability and criticality of harm resulting from this failure mode has been evaluated and were found to be at an acceptable level.A bent trocar is considered not reportable as it is unlikely to cause or contribute to death or serious injury.The event is being reported due to the fracture that was observed on the obturator during evaluation of the returned unit.
Event or Problem Description
Procedure performed: laparoscopic appendix event description: dr (b)(6) was the surgeon, he has used applied medical kii trocars many, many times at this hospital.Incident occurred during cepod list with a high bmi patient having a laparoscopic appendectomy.Pneumo peritoneum was achieved via hasson approach with 12mm kii trocar, second trocar was places successfully, the problem happened on the 3rd trocar (suprapubic) being placed under direct vision.Dr (b)(6) advised me that the patient had very tough peritoneum, the trocar in question essentially bent (did not shatter) whilst trying to get the tip through the tough peritoneum.Another trocar (identical) was opened and successfully inserted.The procedure was successfully completed without any issue or injury to patient.Type of intervention: another trocar was opened and successfully inserted.Patient status: no patient issues.

• Brand Name: CTF12, 5X100 KII FIOS ZTHR DP 10/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9634974
• Report Number: 2027111-2020-00334
• Device Sequence Number: 16936799
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707(17)220527(30)01(10)1356447
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 01/27/2020

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: Health Professional
• Device Expiration Date: 05/27/2022
• Device Model Number: CTF12
• Device Catalogue Number: 101472858
• Device Lot Number: 1356447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1