MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R95, 12X100 KII BLUNT TIP SM CONE 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R95
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: na (before use).Event description: plastic attachment piece cracked off disposable laparoscopic trocar during set-up.No contact with patient, item removed from surgical field.1 item impacted, not a repeat issue.Type of incident/problem: defect (detected before use) level of harm: no effect - did not reach patient - detected before use or does not touch person during use optional report to cmdsnet (health canada): yes, hospital submitted mdip (b)(4) complaint sample is retained for return and is clean/not used product is available for return.Additional information was received via email on 26apr2023 from distributor: the event date should have been (b)(6) 2023.Patient status: na (before use).
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a fractured 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.
Event or Problem Description
Procedure performed: na (before use).Event description: plastic attachment piece cracked off disposable laparoscopic trocar during set-up.No contact with patient, item removed from surgical field.1 item impacted, not a repeat issue.Type of incident/problem: defect (detected before use) level of harm: no effect - did not reach patient - detected before use or does not touch person during use optional report to cmdsnet (health canada): yes, hospital submitted mdip 28804 complaint sample is retained for return and is clean/not used.Product is available for return.Additional information was received via email on 26apr2023 from distributor: the event date should have been april 5 2023.Patient status: na (before use).

• Brand Name: C0R95, 12X100 KII BLUNT TIP SM CONE 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17725690
• Report Number: 2027111-2023-00592
• Device Sequence Number: 20601294
• Product Code: GCJ
• UDI-Device Identifier: 00607915127602
• UDI-Public: (01)00607915127602(17)251026(30)01(10)1467766
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K923636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 10/26/2025
• Device Model Number: C0R95
• Device Catalogue Number: 101234701
• Device Lot Number: 1467766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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
• Patient Sex: Unknown