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	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: robotic laparoscopic myomectomy.Event description: trocar was being used as an ancillary port.Using the ct needle to pass through the trocar when the entire clear shield over the duckbill came off through the trocar and fell into the patient.The shield was retrieved from the patient.The trocar was replaced and the procedure completed.The device is available to be returned.Intervention: replaced with a new trocar.Patient status: no patient injury.
Event or Problem Description
Procedure performed: robotic laparoscopic myomectomy.Event description: trocar was being used as an ancillary port.Using the ct needle to pass through the trocar when the entire clear shield over the duckbill came off through the trocar and fell into the patient.The shield was retrieved from the patient.The trocar was replaced and the procedure completed.The device is available to be returned.Intervention: replaced with a new trocar.Patient status: no patient injury.
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.Engineering observed that the shield had scratches and part of the shield was significantly damaged.Based on the condition of the returned unit and the description of the event, it is likely that the shield was dislodged by the ct needle that was inserted/removed from 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.".

• 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: 9292283
• Report Number: 2027111-2019-00627
• Device Sequence Number: 2172600
• Product Code: GCJ
• UDI-Device Identifier: 00607915115920
• UDI-Public: (01)00607915115920(17)220718(30)01(10)1364080
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/18/2019

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: 07/18/2022
• Device Model Number: C0Q19
• Device Catalogue Number: 101063001
• Device Lot Number: 1364080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: 5MM SUCTION TIP, SH NEEDLE AND DI VINCI GRASPERS