MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF71, KII FIOS 12X150MM Z-THREAD, 6BX; GCJ

Model Number	CTF71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: "laparoscopic right nephrectomy and adrenalectomy." event description: this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation.Cannula fractured.Report from the sales rep: duration of the surgery: 6 hours.During laparoscopic right nephrectomy and adrenalectomy, at the end of the surgery, the center of the cannula was fractured causing the distal part of the cannula to remain inside abdominal cavity.The customer confirmed the distal part of the cannula remained inside abdominal cavity by inserting the doctor's finger into incision and pushed it in the direction from abdominal cavity to abdominal wall.Then the customer removed it from patient with a kelly clamp.The patient's bmi is (b)(6) with large amount of subcutaneous fat and visceral fat.The inserted instrument(snake retractor) was used for pushing and holding organ such as kidney with a large amount of fat, using excessive force under the condition that the range of motion of tilting the trocar was too small due to large subcutaneous fat thickness.It was likely that the large excessive force was applied to the cannula.The customer acknowledged the cannula was fractured because of excessive force applied to the cannula due to the special procedure.Request: however, if the damaged area leads fragmentation, it is likely that a fragment remains inside abdominal cavity.The customer would like to know whether or not the damage area has any missing sections.Please include the answer to the question in the closing letter.Initial investigation report: the event unit was returned to us and visually inspected.The center of the cannula was fractured (fig.1).The damaged section of the distal end of the cannula matched the damaged section of the proximal side of the cannula in shape (fig.2).The unit will be returned to amr for further evaluation.(b)(4).Type of intervention: removed the fractured piece of the cannula from a patient with a kelly clamp.Patient status: "no patient injury.".
Additional Manufacturer Narrative
Additional information: added concomitant medical product used in this event.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 a combination of uneven wall thickness, which occurred during the injection molding process of the cannula, and prolonged lipid exposure.The probability and criticality of harm resulted from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has implemented process enhancements intended to further minimize the potential for this type of incident to occur.

• Brand Name: CTF71, KII FIOS 12X150MM Z-THREAD, 6BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7007164
• Report Number: 2027111-2017-02089
• Device Sequence Number: 1601277
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)191201(30)01(10)1284672
• Combination Product (Y/N): N
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 12/01/2019
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1284672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1