MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB73, 12X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB73
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap/open low anterior resection.Event description: in the case, the blade in the trocar comes out during the trocar insertion to the patient, or the head part comes out at the instrument entrance.In the report prepared by the hospital, [surgeon]'s case of lap/open low anterior resection, the top plastic part of the product that was opened could not be used because it did not fit and came off.Patient status: patient is safe post surgery.
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: lap/open low anterior resection.Event description: in the case, the blade in the trocar comes out during the trocar insertion to the patient, or the head part comes out at the instrument entrance.In the report prepared by the hospital, [surgeon]'s case of lap/open low anterior resection, the top plastic part of the product that was opened could not be used because it did not fit and came off.Additional information provided by applied medical representative via email 20oct21: the product was in the hospital and the hospital sent it to the distributor late without informing them.During the operation, the doctor said that the head part of the trocar was moving when the instrument was inserted into the trocar and it was dislodged.The doctor continued the operation and a new product was opened.The doctor completed the surgery with the new product.The hospital did not want a replacement.Intervention: change of device.Patient status: patient is safe post surgery.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the returned unit, which confirmed that the seal could be removed without pressing a cannula wing tab.The distance between the wing tabs was measured and found to be undersized.The bladed obturator functioned as intended and there were no visible non-conformances.Based on the condition of the returned unit and event description, it is likely that the seal detached from the cannula due to the undersized wing tab distance.However, the exact root cause of the undersized wing tab distance is unknown.This event was initially reported based on the initial description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.Update to section g2: added company representative as a report source.

• Brand Name: CTB73, 12X100 KII SH BLD ZTHR 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: 12674100
• Report Number: 2027111-2021-00687
• Device Sequence Number: 4530307
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)231105(30)01(10)1396691
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K072674
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 11/05/2023
• Device Model Number: CTB73
• Device Catalogue Number: 101472289
• Device Lot Number: 1396691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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