MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R47
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was returned to applied medical for evaluation, along with a black fragment and a clear component.Visual inspection confirmed the complainant¿s experience of seal component separation and particulation.The returned black fragment matched the missing portion of the septum, an internal rubber component of the seal.The clear component was identified to be the shield, an internal plastic component of the seal.Based on the condition of the returned unit, it is likely that the fragmented septum and dislodged shield were caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical¿s instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.".
Event or Problem Description
Procedure performed: pancreaticoduodenectomy.Event description: report from the sales rep via email; the surgeon felt resistance when inserting the retrieval bag[brand name], and when he pushed it in, the black component, which appeared to be a trocar valve, fell out into the abdominal cavity.Additional information received on29 may 2024 by applied medical represenative: this event was determined to be a part of a septum or duckbill that fell.Type of intervention: the dropped valves were recovered.Patient status: no impact.

• Brand Name: C0R47, 12X100 KII BALLOON BLUNT TIP 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: 19589627
• Report Number: 2027111-2024-00707
• Device Sequence Number: 11598190
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453(17)260530(30)01(10)1492351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060629
• 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
• Report Date (Section B): 06/21/2024

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: 05/30/2026
• Device Model Number: C0R47
• Device Catalogue Number: 101246101
• Device Lot Number: 1492351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• 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: 05/03/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: COLLECTION BAG.
• Patient Sex: Unknown