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	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with the shield, a clear plastic component of the seal.Visual inspection of the event unit confirmed the complainant's experience of seal component separation.The duckbill and septum, rubber components of the seal, were torn.Based on the condition of the returned unit, it is likely that the reported event was 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: lap hysterectomy sacrocolpopexy.Event description: limited information available at the time of report.Inside seal tore and two pieces fell into the patient.The pieces were retrieved from the patient.Rep was not told what part of the seal was torn or the color of the component.Asked what instrumentation was being used at the time but the information was unknown.It is unknown if they were able to complete the case with the event device or opened another trocar.Device is available and will be returned.Intervention: the pieces were retrieved from the patient.Patient status: fine.

• 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: 9079422
• Report Number: 2027111-2019-00590
• Device Sequence Number: 2449776
• Product Code: GCJ
• UDI-Device Identifier: 00607915115920
• UDI-Public: (01)00607915115920(17)200727(30)01(10)1301163
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 09/17/2019

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: 07/27/2020
• Device Model Number: C0Q19
• Device Catalogue Number: 101063001
• Device Lot Number: 1301163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1