MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR12, 5X100 KII OPT ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR12
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: lap appendectomy.Event description: additional information received from applied medical representative via email on 7-mar-2022: the patient had 2 previous c-sections as their only previous surgery.During the procedure there was lots of twisting and pushing.After about 15 minutes of trying the trocar entered the abdomen with the tip hanging off slightly.The registrar used a grasper to remove the tip before it could drop into the space.The trocar was then removed and replaced with another without issues the procedure was a lap appendectomy.This was the third trocar placed, 2 others were already in place.The trocar was inserted under vision.Other than the other trocars, there were no instruments in the operating field.The trocar was inserted below the umbilicus, left abdominal.As far as the customer is aware, the tip of the obturator did not come into contact with hard/dense surfaces.In surgery, the staff was happy with the retrieval, however confirmation will follow if all pieces were retrieved.The device has been disposed of.Intervention: change of device.Patient status: unaware.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a fractured obturator tip.Based on the event description and the photos provided, it is likely that the reported event was caused by high insertion force that caused the obturator tip to fracture during insertion.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.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: lap appendectomy.Event description: additional information received from applied medical representative via email on 7-mar-2022: the patient had 2 previous c-sections as their only previous surgery.During the procedure there was lots of twisting and pushing.After about 15 minutes of trying the trocar entered the abdomen with the tip hanging off slightly.The registrar used a grasper to remove the tip before it could drop into the space.The trocar was then removed and replaced with another without issues the procedure was a lap appendectomy.This was the third trocar placed, 2 others were already in place.The trocar was inserted under vision.Other than the other trocars, there were no instruments in the operating field.The trocar was inserted below the umbilicus, left abdominal.As far as the customer is aware, the tip of the obturator did not come into contact with hard/dense surfaces.In surgery, the staff was happy with the retrieval, however confirmation will follow if all pieces were retrieved.The device has been disposed of.Intervention: change of device.Patient status: unaware.

• Brand Name: CTR12, 5X100 KII OPT ZTHR DP 10/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: 13715789
• Report Number: 2027111-2022-00461
• Device Sequence Number: 6286926
• Product Code: GCJ
• UDI-Device Identifier: 00607915123505
• UDI-Public: (01)00607915123505(17)240726(30)01(10)1420990
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060096
• 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): 05/23/2022

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: 07/26/2024
• Device Model Number: CTR12
• Device Catalogue Number: 101094501
• Device Lot Number: 1420990
• Was Device Available for Evaluation?: No
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 OTHER TROCARS.
• Patient Sex: Unknown