MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS12, 11X100 KII Z-THR SLV, 12/BX; GCJ

Model Number	CTS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: during a laparoscopic cholecystectomy procedure a small piece of plastic was seen and retrieved.This was later discovered to be from the port itself and not from any other instrumentation.The piece matching the port.Type of intervention: piece of plastic was seen and retrieved.Patient status: no injuries noted by the surgeon.No harm caused.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a rubber fragment.Visual inspection confirmed the complainant's experience of seal component separation.The rubber fragment completed the missing portion on the septum, a rubber component of the seal.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by an instrument.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." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: CTS12, 11X100 KII Z-THR SLV, 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6978600
• Report Number: 2027111-2017-02081
• Device Sequence Number: 16368884
• Product Code: GCJ
• UDI-Device Identifier: 00607915124267
• UDI-Public: (01)00607915124267(17)200328(30)01(10)1293506
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: Other
• Device Expiration Date: 03/28/2020
• Device Model Number: CTS12
• Device Catalogue Number: 101244901
• Device Lot Number: 1293506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1