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

Model Number	CTF71
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: robotic hysterectomy.Event description: "during the procedure the ctf71 was being utilized as the scope port which was placed in the umbilicus.During the case i was told that they removed the robotic scope several times to clean the lens.At the end when the surgeon removed the ctf71, he noticed approximately 30 to 40 percent of the distal tip of the trocar was missing.Upon further examination, this missing portion of the trocar was located in the patient's fascia.It was subsequently removed and the case was completed.The ctf71 was removed, disinfected and bagged for return to applied." the trocar was not noted to be reprocessed before use.Additional information received via email 21sep2021 from applied medical representative: the patient was fine after the case.The break occurred on the shaft.This break/fracture did not cause any particulation.The clamp used was [non-applied medical device].Product is available for return.Intervention: the missing portion of the trocar was "subsequently removed and the case was completed." patient status: the patient was fine after the case.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula.The distal section of the cannula, near the fracture location, was melted and scratched with a hole.The wall thickness of the cannula near the fracture location was measure and found to be uneven and did not meet specifications.Based on the condition of the returned, it is likely that the cannula fracture was caused by instrumentation (possibly heat-producing) used during the procedure, or the uneven cannula and out of specifications wall thickness, or a combination of both.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 hysterectomy event description: "during the procedure the ctf71 was being utilized as the scope port which was placed in the umbilicus.During the case i was told that they removed the robotic scope several times to clean the lens.At the end when the surgeon removed the ctf71, he noticed approximately 30 to 40 percent of the distal tip of the trocar was missing.Upon further examination, this missing portion of the trocar was located in the patient's fascia.It was subsequently removed and the case was completed.The ctf71 was removed, disinfected and bagged for return to applied." the trocar was not noted to be reprocessed before use.Additional information received via email 21sep2021 from applied medical representative: the patient was fine after the case.The break occurred on the shaft.This break/fracture did not cause any particulation.The clamp used was [non-applied medical device].Product is available for return.Intervention: the missing portion of the trocar was "subsequently removed and the case was completed." patient status: the patient was fine after the case.

• Brand Name: CTF71, KII FIOS 12X150MM Z-THREAD, 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12541853
• Report Number: 2027111-2021-00651
• Device Sequence Number: 4307152
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)221215(30)01(10)1376524
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 12/15/2022
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1376524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTUITIVE 371528-03 DA121001
• Patient Sex: Unknown