MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR24, 5X100 KII LP OPT ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR24
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown.Event description: tip of cannular broke off, leaving 2 fragments inside patient when removed.The surgeon managed to successfully retrieve the fragments.Patient status: unknown.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: tip of cannular broke off, leaving 2 fragments inside patient when removed.The surgeon managed to successfully retrieve the fragments.Product complaint form: on (b)(6) 2023: tip of port broke off in at least two fragments that were left in patient after port taken out.Surgeon successfully gathered broken off fragments by investigating port site.Patient status: unknown.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photographs of the event unit were provided, which confirmed the complainant's experience of a fractured cannula at the tip.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.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.

• Brand Name: CTR24, 5X100 KII LP 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: 16941259
• Report Number: 2027111-2023-00456
• Device Sequence Number: 7206112
• Product Code: GCJ
• UDI-Device Identifier: 00607915126513
• UDI-Public: (01)00607915126513(17)250727(30)01(10)1460644
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/08/2023

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: 07/27/2025
• Device Model Number: CTR24
• Device Catalogue Number: 101180101
• Device Lot Number: 1460644
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown