MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic tubal ligation.Event description: the rep.Wasn't present for the case.Stated that the trocar was already in the patient when the cannula broke and didn't occur during insertion.It occurred at the distal end of the cannula.The fracture did cause particulation and the doctor was able to retrieve the two pieces from the patient.The port was not used with a robot and method of insertion is currently unknown at this time.Per the rep., he stated that the surgeon "pieced [the pieces back] together like a puzzle to make sure he had all the pieces." there was no patient injury and intervention is currently unknown at this time.No photos are available, but the product is available for return.Patient status: no patient injury occured.
Event or Problem Description
Procedure performed: laparoscopic tubal ligation.Event description: the rep.Wasn't present for the case.Stated that the trocar was already in the patient when the cannula broke and didn't occur during insertion.It occurred at the distal end of the cannula.The fracture did cause particulation and the doctor was able to retrieve the two pieces from the patient.The port was not used with a robot and method of insertion is currently unknown at this time.Per the rep., he stated that the surgeon "pieced [the pieces back] together like a puzzle to make sure he had all the pieces." there was no patient injury and intervention is currently unknown at this time.No photos are available, but the product is available for return.Additional information was received from applied medical account manager, via telephone on september 26th, 2019: the rep.Had a chance to speak with the surgeon who stated that it was a patient specific issue, i.E.The tissue was really tough and trying to access the abdomen was difficult.The surgeon managed to reach the peritoneum near the fascia, but never penetrated the abdomen.The fracture occurred some time during the process of when the doctor was trying to insert the trocar into the patient's body.A scope was used alongside the trocar.Per the rep., when the surgeon put the scope into the trocar, that is when he noticed that the cannula had broken.The pieces were retrieved and the doctor converted to an open procedure to complete the case.The doctor stated multiple times that he thought it was patient anatomy that resulted in the cannula breaking.Additional information was received from applied medical account manger, via e-mail on october 7th, 2019: the rep.Was asked for clarification in regards to the doctor converting to an open procedure to complete the case - it was asked whether or not the conversion was necessary as a direct result of the cannula fracture or if it was due to the condition of the patient's tissue being the deciding factor in converting to an open procedure.Per the rep., "the doctor said he felt the patients tough tissue would continue to make it difficult to put trocars in and he felt open would be best option for him." intervention: completed the case by converting to an open procedure.Patient status: no patient injury occured.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by excessive forces applied on the cannula in combination with uneven wall thickness, which occurred during the injection molding process of the cannula.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 6/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: 9111444
• Report Number: 2027111-2019-00596
• Device Sequence Number: 3174129
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)211108(30)01(10)1341720
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/09/2019

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: 11/08/2021
• Device Model Number: CTF01
• Device Catalogue Number: 101412701
• Device Lot Number: 1341720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE