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)
Date of Event	08/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Laparoscopic pancreatectomy -: "surgeon noticed that when he came to use the clip applier it had a piece of black rubber lodged on the clip applier, surgeon removed the clip applier and the cts12 port.He inserted a new cts12 to finish of the procedure where there were no further problems.The team packaged the port and piece of rubber ready for it to be returned to applied medical." patient status - recovered in the ward and was discharged.Type of intervention - n/a.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation along with the fragment retrieved during the procedure.Visual inspection confirmed that the septum had fragmented, the returned fragment matched the missing section of the septum.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of the event is likely due to damage caused by instruments.As stated in the instructions for use, "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." although the root cause could not be confirmed, applied medical has opened a corrective and preventative action (capa) to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• 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: 6045991
• Report Number: 2027111-2016-00717
• Device Sequence Number: 18895879
• Product Code: GCJ
• UDI-Device Identifier: 00607915124267
• UDI-Public: (01)00607915124267(17)190128(30)01(10)1264200
• 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): 12/16/2016

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: 01/28/2019
• Device Model Number: CTS12
• Device Catalogue Number: 101244901
• Device Lot Number: 1264200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2016
• Supplement Report FDA Received Date: 12/16/2016
• 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: CTF33, CTF03, CTS12, CTS02, 10MM SCOPE; REUSABLE GRASPERS, DISSECTORS, SCISSORS; VIALTEC REPOSABLE CLIP APPLIER