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	01/22/2019
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: da vinci prostatectomy: during the surgery the lower part of the cannula broke off, fell into the abdominal cavity and could apparently be retrieved completely.Damage due to an instrument was deemed impossible by the customer.Additional information received from sales representative via phone on 23jan2019: the incident occurred while removing the trocar, at the very end of the surgery.The surgeon noticed that the trocar seemed to be stuck, but could then remove the trocar.That¿s when the fracture was noticed.According to the customer, the surgery was very difficult because the patient is obese.The surgeon did not have any indication that the cannula had broken during the surgery; no cracks, no noticeable impact of instruments against the cannula this trocar was used as an ancillary port, not as a port for the davinci xi the sales representative was informed about this incident by phone, but was not present during the surgery.As the customer indicated that the fracture occurred in the lower third of the cannula and that he was able to assemble the pieces, it¿s likely that it was a clean break.Patient status: no patient injury.
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 the cannula fracture was caused by the 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.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.
Event or Problem Description
Procedure performed: da vinci prostatektomie.Event description: intraoperativ ist der untere teil der hülse abgebrochen, in den bauchraum gefallen und konnte offensichtlich komplett geborgen werden.Eine beschädigung durch ein instrument hat der kunde ausgeschlossen.Translation ame: during the surgery the lower part of the cannula broke off, fell into the abdominal cavity and could apparently be retrieved completely.Damage due to an instrument was deemed impossible by the customer.Additional information received from sales representative via phone on 23jan2019: the incident occurred while removing the trocar, at the very end of the surgery.The surgeon noticed that the trocar seemed to be stuck, but could then remove the trocar.That¿s when the fracture was noticed.According to the customer, the surgery was very difficult because the patient is obese.The surgeon did not have any indication that the cannula had broken during the surgery; no cracks, no noticeable impact of instruments against the cannula this trocar was used as an ancillary port, not as a port for the davinci xi the sales representative was informed about this incident by phone, but was not present during the surgery.As the customer indicated that the fracture occurred in the lower third of the cannula and that he was able to assemble the pieces, it's likely that it was a clean break.Patient status: no patient injury.

• 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: 8449035
• Report Number: 2027111-2019-00395
• Device Sequence Number: 3057498
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)191109(30)01(10)1282956
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 11/09/2019
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1282956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1