MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF71, KII FIOS 12X150MM Z-THREAD, 6BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: robotic right ovarian cystectomy.Event description: the tip of the cannula broke.The break did not cause particulation.The robot model is unknown.The brand and size of the clamp are unknown.There was no patient injury and the product is expected to return.Additional information was received from applied medical account manager associate, via e-mail on june 16, 2020: "the surgeon was using the si robot and using the trocar as the camera port trocar.It was already in the abdominal cavity with the camera in place but the surgeon was still manually in control of the camera (was not yet controlling it robotically).The patient was small so the ports were close together.The lateral robotic ports were also in.She moved the camera in order to visualize the instrument entering one of the robotic ports.When she moved the camera the port clashed with the other robotic port and broke.The pieces were retrieved to the best of their knowledge unless shards of plastic broke off.Surgeon emphasized she had not yet switched to robotic controls it was still manual." the break was identified during use.One piece was in the patient, but "they believe it was all retrieved." the port was used with a robot as the camera port.The surgeon was unaware of the clamp size used, "but assumed brand was davinci." patient status: no patient injury occurred.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken cannula.The fragment was not returned for evaluation.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by two ports that made contact with each other during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: robotic right ovarian cystectomy.Event description: the tip of the cannula broke.The break did not cause particulation.The robot model is unknown.The brand and size of the clamp are unknown.There was no patient injury and the product is expected to return.Additional information was received from applied medical account manager associate, via e-mail on june 16, 2020: "the surgeon was using the si robot and using the trocar as the camera port trocar.It was already in the abdominal cavity with the camera in place but the surgeon was still manually in control of the camera (was not yet controlling it robotically).The patient was small so the ports were close together.The lateral robotic ports were also in.She moved the camera in order to visualize the instrument entering one of the robotic ports.When she moved the camera the port clashed with the other robotic port and broke.The pieces were retrieved to the best of their knowledge unless shards of plastic broke off.Surgeon emphasized she had not yet switched to robotic controls it was still manual." the break was identified during use.One piece was in the patient, but "they believe it was all retrieved." the port was used with a robot as the camera port.The surgeon was unaware of the clamp size used, "but assumed brand was davinci." patient status: no patient injury occurred.

• Brand Name: CTF71, KII FIOS 12X150MM Z-THREAD, 6BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10163987
• Report Number: 2027111-2020-00479
• Device Sequence Number: 2400844
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)230105(30)01(10)1378409
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/09/2020

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: 01/05/2023
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1378409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 09/09/2020
• 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: DAVINCI SI ROBOT