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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: robotic gastric sleeve.Event description: limited information available at the time of the report.It was reported that the trocar broke.It is unknown where the breakage occurred.It is unknown at what point the break was identified.It is unknown if any pieces fell into the patient.It is unknown how the case was completed.There was no patient injury.The device was discarded after the case.Additional information received via email on (b)(6) 2021 from applied medical account mgr: i was contacted on (b)(6) 2021.The case was a robotic gastric sleeve, cannula cracked near the seal cap, no patient injury, surgeon was dr.[name].Patient status: no patient injury.
Event or Problem Description
Procedure performed: robotic gastric sleeve.Event description: limited information available at the time of the report.It was reported that the trocar broke.It is unknown where the breakage occurred.It is unknown at what point the break was identified.It is unknown if any pieces fell into the patient.It is unknown how the case was completed.There was no patient injury.The device was discarded after the case.Additional information received via email on (b)(6) 2021 from applied medical account mgr: i was contacted on (b)(6) 2021.The case was a robotic gastric sleeve, cannula cracked near the seal cap, no patient injury, surgeon was dr.[name].Additional information received via email on (b)(6) 2021 from applied medical account mgr: the trocar was used as a camera port trocar on an si intuitive robot.The coupler was for an applied port.There was a crack in the trocar near the seal cap that was noticed at the end of the case.No new trocar was used.There was no part of the trocar that entered the patient.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.Based on the event description and previous incidents, it is likely that the reported event was caused by improper robotic arm clamp installation or the method in which the robotic device was being used in the procedure.However, the exact root cause could not be confirmed.

• 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: 11648904
• Report Number: 2027111-2021-00441
• Device Sequence Number: 3697928
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)220228(30)01(10)1349772
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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: 02/28/2022
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1349772
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/18/2021
• Patient Sequence Number: 1