MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB35, 11X100 KII SH BLD Z-THRD DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB35
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A fragmented cannula wing tab from the event unit was returned to applied medical for evaluation.Visual inspection of the wing tab confirmed the complainant¿s experience.A non-event unit was also returned to applied medical.The non-event unit met current specifications and there were no visible non-conformances.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.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.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: unknown.Event description: "trocar kit #1 is used.When trocar #11 is used, a piece of the same material falls into the patient, and the piece is successfully extracted." product is available for return.Intervention: the piece was successfully extracted.Patient status: unknown.

• Brand Name: CTB35, 11X100 KII SH BLD Z-THRD 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: 15433317
• Report Number: 2027111-2022-00734
• Device Sequence Number: 20334964
• Product Code: GCJ
• UDI-Device Identifier: 00607915129897
• UDI-Public: (01)00607915129897(17)240120(30)01(10)1406029
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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: 01/20/2024
• Device Model Number: CTB35
• Device Catalogue Number: 101473280
• Device Lot Number: 1406029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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 Age: 54 YR
• Patient Sex: Female