MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF74, KII 12X100 FIOS Z-THR HN 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF74
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: laparoscopic adrenalectomy event description: product snapped into two pieces, leaving one piece in the patient where they then had to widen the incision to remove from the patient.Additional information provided by hospital via email 15oct21: there was no injury to the patient.It happened at the beginning of the procedure.I still have the port.Additional information provided by hospital via email 18oct21: it happened near the start of the procedure, which was a posterior laparoscopic adrenalectomy.The patient is placed in a prone jack-knife position and 3 ports are inserted through the back.It was the medial port that snapped, this was placed via palpation and we have never had this problem before.As it was in the retroperitoneal space it was difficult to retrieve the snapped end as there isn't a large space to find it so was technically challenging.Intervention: component removed.Patient status: no injury to the patient.
Event or Problem Description
Procedure performed: laparoscopic adrenalectomy.Event description: product snapped into two pieces, leaving one piece in the patient where they then had to widen the incision to remove from the patient.Additional information provided by hospital via email 15oct21: there was no injury to the patient.It happened at the beginning of the procedure.I still have the port.Additional information provided by hospital via email 18oct21: it happened near the start of the procedure, which was a posterior laparoscopic adrenalectomy.The patient is placed in a prone jack-knife position and 3 ports are inserted through the back.It was the medial port that snapped, this was placed via palpation and we have never had this problem before.As it was in the retroperitoneal space it was difficult to retrieve the snapped end as there isn't a large space to find it so was technically challenging.Intervention: component removed.Patient status: no injury to the patient.
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 wall thickness of the cannula near the fracture location was measured and was found to be out of specification.Based on the condition of the returned unit, it is likely that the reported event was caused by the cannula wall thickness that was found to be out of specification, which could potentially cause the cannula to be more susceptible to fracture.

• Brand Name: CTF74, KII 12X100 FIOS Z-THR HN 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: 12665933
• Report Number: 2027111-2021-00682
• Device Sequence Number: 19891991
• Product Code: GCJ
• UDI-Device Identifier: 00607915123710
• UDI-Public: (01)00607915123710(17)230807(30)01(10)1392250
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: 08/07/2023
• Device Model Number: CTF74
• Device Catalogue Number: 101470925
• Device Lot Number: 1392250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2020
• 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
• Patient Sex: Unknown