MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB33, 11X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB33
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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: hernia.Event description: per customer experience report: in the surgery, the wing tab was broken suddenly.Additional information received via email 01nov2021 from [distributor]: the break was identified about an hour later.The trocar was inserted without any rotation.The break was considered not clean and partially broken.The break did not cause any particulation.The trocar was not used with a robot.At the time of the incident, the grasper was inside of the cannula.Additional information received via email 02nov2021 from [distributor]: the case was completed by replacing the trocar with a new one.Intervention: the case was completed by replacing the trocar with a new one.Patient status: fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a green fragment.Visual inspection confirmed the complainant¿s experience of a broken cannula wing tab.The green fragment completed the missing portion of the broken cannula wing tab.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.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: hernia.Event description: per customer experience report: in the surgery, the wing tab was broken suddenly.Additional information received via email on (b)(6) 2021 from [distributor]: the break was identified about an hour later.The trocar was inserted without any rotation.The break was considered not clean and partially broken.The break did not cause any particulation.The trocar was not used with a robot.At the time of the incident, the grasper was inside of the cannula.Additional information received via email on (b)(6) 2021 from [distributor]: the case was completed by replacing the trocar with a new one.Intervention: the case was completed by replacing the trocar with a new one.Patient status: fine.

• Brand Name: CTB33, 11X100 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: 12796857
• Report Number: 2027111-2021-00713
• Device Sequence Number: 12063962
• Product Code: GCJ
• UDI-Device Identifier: 00607915124250
• UDI-Public: (01)00607915124250(17)240523(30)01(10)1415736
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 05/23/2024
• Device Model Number: CTB33
• Device Catalogue Number: 101219501
• Device Lot Number: 1415736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• 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: 10/28/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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