MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS12, 11X100 KII SLEEVE ZTHR 12/BX; GCJ

Model Number	CTS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: the black part inside the seal fell in the patient abdomen then was successfully retrieved.This event occurred at the end of the surgery during exsufflation.Additional information received via email from user facility on 03 august 2017: a 5mm black piece of a trocar valve has detached in the patient's abdomen.Seen during exsufflation at the end of the intervention.Type of intervention: unknown.Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of fragmentation of an internal rubber component of the seal.Based on the condition of the returned, it is likely that the damage to the seal was caused by an instrument.The instructions for use (ifu) states, "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 continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible device enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: CTS12, 11X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6810294
• Report Number: 2027111-2017-01953
• Device Sequence Number: 16584636
• Product Code: GCJ
• UDI-Device Identifier: 00607915124267
• UDI-Public: (01)00607915124267(17)200328(30)01(10)1293505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/25/2017

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: 1293505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1