MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII BALLOON BLUNT TIP SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R47
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: total laparoscopic hysterectomy.Event description: complaint (b)(4), complaint 1 of 3.Complaint (b)(4), complaint 2 of 3.Complaint (b)(4), complaint 3 of 3.The device was being used for camera insertion through port.Dr.[name] and dr [name] commented that the 10mm zero-degree camera did not slide in properly and felt like it didn't fit like it usually does.They asked [name] to return device as faulty and to investigate.There was no clinical impact to the patient as a result of the event.Force and maneuvering the camera eventually worked and camera went down the port which allowed the user to resolve the situation.Additional information was received from territory manager via email on (b)(4) 2024: "i have spoken to the account, and they know of 3 total incidents.So far: 2 x ctf33 and 1 x c0r47.In all cases, they continued using the trocar despite the resistance." intervention: force and maneuvering the camera eventually worked and camera went down the port.Patient status: stable, no complications.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: total laparoscopic hysterectomy.Event description: complaint (b)(4), complaint 1 of 3.(medwatch report id: 2027111-2024-00815).Complaint (b)(4), complaint 2 of 3.(medwatch report id: 2027111-2024-00816).Complaint (b)(4), complaint 3 of 3.(medwatch report id: 2027111-2024-00826).The device was being used for camera insertion through port.Dr.[name] and dr [name] commented that the 10mm zero-degree camera did not slide in properly and felt like it didn't fit like it usually does.They asked [name] to return device as faulty and to investigate.There was no clinical impact to the patient as a result of the event.Force and maneuvering the camera eventually worked and camera went down the port which allowed the user to resolve the situation.Additional information was received from territory manager via email on 27-aug-2024: i have spoken to the account, and they know of 3 total incidents.So far: 2 x ctf33 and 1 x c0r47.In all cases, they continued using the trocar despite the resistance.Intervention: force and maneuvering the camera eventually worked and camera went down the port.Patient status: stable, no complications.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.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.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.

• Brand Name: KII BALLOON BLUNT TIP SYSTEM
• 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: 20103081
• Report Number: 2027111-2024-00816
• Device Sequence Number: 7664644
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K060629
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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 Model Number: C0R47
• Device Catalogue Number: 101246101
• Device Lot Number: 1513423
• Was Device Available for Evaluation?: No
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown