MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0Q19, KII 8X100 Z-THR OPT SYS 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0Q19
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: robotic sacrocolpopexy.The rep was not present during the case.During the middle of the case the clear plastic component, normally located above the double duckbill seal in the trocar, fell into the patient.The entire component fell into the patient.The instruments being used through the trocar are unknown.Unknown if the component was discovered immediately once it fell into the patient or later in the case.The component was retrieved from the patient.No patient injury.Intervention: piece removed from patient.Patient status: no patient injury.
Additional Manufacturer Narrative
A single component of the event device was returned to applied medical for evaluation.Visual inspection confirmed that the shield, an internal plastic component of the seal, had detached from the seal.Engineering observed that the shield petals were scratched and damaged.Based on the condition of the shield and the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of instruments (needle) 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: robotic sacrocolpopexy.Event description: the rep was not present during the case.During the middle of the case the clear plastic component, normally located above the double duckbill seal in the trocar, fell into the patient.The entire component fell into the patient.The instruments being used through the trocar are unknown.Unknown if the component was discovered immediately once it fell into the patient or later in the case.The component was retrieved from the patient.No patient injury.Additional information received via email on 09nov2020 from applied medical team member: "this clear portion of the seal pictured is what fell into the patient during the robotic assisted sacrocolpopexy.I spoke with [] and he told me that this was used as his assist port and a needle driver was being used when this happened.I do not know if the trocar was used to finish the case or if another was opened." intervention: piece removed from patient patient status: no patient injury.

• Brand Name: C0Q19, KII 8X100 Z-THR OPT SYS 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10683753
• Report Number: 2027111-2020-00581
• Device Sequence Number: 2961787
• Product Code: GCJ
• UDI-Device Identifier: 00607915115920
• UDI-Public: (01)00607915115920(17)230626(30)01(10)1384939
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 06/26/2023
• Device Model Number: C0Q19
• Device Catalogue Number: 101063001
• Device Lot Number: 1384939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEEDLE DRIVER