MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB03, 5X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
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 cholecystectomy.Event description: dr.[name] mentions he was about to introduce the 5x100mm trocar into the cavity with the activation mechanism window in red and he was unable to introduce the trocar, while the activation mechanism became deactivated, he activated it again and tried to introduce the trocar with no success, he mentions on the third attempt to introduce the trocar into the abdominal cavity the trocar bended and broke, he then asked for a new trocar and was able to introduce it and complete the surgery.Product available to be returned.Additional information was received on 12sept2022 via email by applied medical representatives: in the complaint, it was the first trocar to be placed through the umbilical incision.The broken was not considered clean, since the broken was partial, no particulation was caused.Note: it was the cannula that partially broke, the obturator was only bent.And the trocar that will be sent (the cannula is already broken, it finished breaking and/or detaching when the technician washed it).Intervention: new trocar and was able to introduce it and complete the surgery.Patient status: good.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy event description: dr.[name] mentions he was about to introduce the 5x100mm trocar into the cavity with the activation mechanism window in red and he was unable to introduce the trocar, while the activation mechanism became deactivated, he activated it again and tried to introduce the trocar with no success, he mentions on the third attempt to introduce the trocar into the abdominal cavity the trocar bended and broke, he then asked for a new trocar and was able to introduce it and complete the surgery.Product available to be returned.Additional information was received on 12sept22 via email by applied medical representatives: in the complaint, it was the first trocar to be placed through the umbilical incision.The broken was not considered clean, since the broken was partial, no particulation was caused.Note: it was the cannula that partially broke, the obturator was only bent.And the trocar that will be sent (the cannula is already broken, it finished breaking and/or detaching when the technician washed it).Intervention: new trocar and was able to introduce it and complete the surgery.Patient status: good.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with the fractured cannula shaft.Visual inspection confirmed the complainant¿s experience of a fractured cannula shaft.The wall thickness of the cannula shaft near the fracture was measured and met specifications.Based on the condition of the returned unit, it is likely that the fractured cannula was due to excessive forced exerted on the unit during insertion.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTB03, 5X100 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: 15485703
• Report Number: 2027111-2022-00741
• Device Sequence Number: 5224707
• Product Code: GCJ
• UDI-Device Identifier: 00607915123512
• UDI-Public: (01)00607915123512(17)250410(30)01(10)1447277
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 04/10/2025
• Device Model Number: CTB03
• Device Catalogue Number: 101138301
• Device Lot Number: 1447277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2022
• Supplement Date Received by Manufacturer: 09/10/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2022
• 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: NEW CTB03
• Patient Sex: Unknown