MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R39, KII 15X150MM Z-THR OPT SEP SYS 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R39
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	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with a rubber fragment and the shield, a clear plastic internal component of seal.Visual inspection confirmed the complainant's experience of seal component separation.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instrumentation through the trocar.Applied medical¿s instructions for use 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 right upper lobectomy.Event description: a trocar broke.No patient injury occurred.Limited information was available at the time of reporting.Additional information received via telephone from account manager on wednesday, 18apr2019: the model number is c0r39.The lot number is 1331889.This is the only information available at this time.Additional information received via telephone on 22apr2019 from account manager: case was a robotic right upper lobectomy.Multiple instruments and large rolled pieces of gauze were placed through the trocar.Large pieces of gauze were being put down the trocar at the time the black piece of the seal broke.It went down the cannula and into the patient.The seal was retrieved with a grasper as soon as it happened.Opened a new trocar (same model) and continued the case.Type of intervention: retrieved seal from the patient.Opened a new trocar.Patient status: no patient injury occurred associated with the complaint event.

• Brand Name: C0R39, KII 15X150MM Z-THR OPT SEP 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: 8717272
• Report Number: 2027111-2019-00484
• Device Sequence Number: 11183780
• Product Code: GCJ
• UDI-Device Identifier: 00607915116446
• UDI-Public: (01)00607915116446(17)210717(30)01(10)1331889
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/20/2019

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: No Information
• Device Expiration Date: 07/17/2021
• Device Model Number: C0R39
• Device Catalogue Number: 101415901
• Device Lot Number: 1331889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1