MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB12, 5X100 KII SH BLD ZTHR DP 10/BX; GCJ

Model Number	CTB12
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report serves as both the initial and final report.When engineering conducted their investigation, a crack was found in the cannula, therefore making this a reportable case.Additional information was requested from the customer and provided.Investigation summary: the event unit was returned for evaluation.Upon inspection, visual and functional testing revealed the cannula was bent and cracked.Engineering confirmed the customer's experience of having difficulty inserting the obturator into the cannula, due to the bend in the cannula.Visual inspection and switch actuation testing indicated that the stainless steel blade and obturator were not bent, and performed per specifications.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Although the root cause of the cracked cannula could not be confirmed, it is possible the result of this incident may be due to manufacturing.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Lap chole - "trocar bent." additional information received via email 20 june 2016: what procedure was being performed? lap chole.What is the patient?s status? n/a-this trocar was not used on patient.At what point in the procedure was the non-conformance identified? before entry/introduction ? when scrub nurse attempted to place obturator into cannula, it would not fit, as the blade was bent.Was the trocar replaced? yes.Did the trocar crack at all? unknown." patient status - "this trocar was not used on the patient." type of intervention - unknown.

• Brand Name: CTB12, 5X100 KII SH BLD ZTHR DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6038881
• Report Number: 2027111-2016-00692
• Device Sequence Number: 75811
• Product Code: GCJ
• UDI-Device Identifier: 00607915123529
• UDI-Public: (01)00607915123529(17)190203(30)01(10)1264559
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K072674
• 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
• Report Date (Section B): 06/16/2016

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: 02/03/2019
• Device Model Number: CTB12
• Device Catalogue Number: 101413701
• Device Lot Number: 1264559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2016
• Initial Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1