MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX; GCJ

Model Number	CTB71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2016
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 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
By-pass - "this incident was reported on (b)(6) 2016 by the department of digestive surgery of (b)(6) hospital.Indeed, by removing the trocar at the end of surgery, the surgeon found that the distal end of the trocar was broken.A liver retractor was introduced during surgery and was supported by an articulated arm, which was secured to the operating table.There was no particular shock during the procedure.The piece of plastic that detached from the trocar, found in the abdominal cavity, was recovered by the surgeon.We will make an optional declaration to the (b)(6)." original: "cet incident a été signalé le (b)(6) 2016 par le service de chirurgie digestive de l'hôpital de (b)(6).En effet, en retirant le trocart à la fin de l'intervention, le chirurgien a repéré que l'extrémité distale du trocart était cassée.Un écarteur à foie a été introduit au cours de l'intervention et était soutenu par un bras articulé, lui-même fixé à la table d?opération.Il n'y a pas eu de choc particulier pendant l'intervention.Le morceau de plastique qui s'est détaché du trocart, retrouvé dans la cavité abdominale, a été récupéré par le chirurgien.Nous allons faire une déclaration facultative à l'(b)(6)." additional information received from applied medical representative on december 07, 2016: the distal part of the cannula broke.It was a clean break.Patient status - no patient injury.
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Investigation summary: the event product was returned to applied medical for evaluation.Upon inspection, engineering was able to confirm the complainant's experience of a fractured cannula.The wall thickness of the cannula was measured, and the measurements did not meet specifications.The likely root cause of the uneven cannula wall thickness is due to the injection molding process of the cannula.The probability and criticality of harm resulting from this failure mode has been evaluated and was found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this continuous process, applied medical is currently researching possible process enhancements intended to further minimize the potential for this type of incident to occur.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.

• Brand Name: CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6209602
• Report Number: 2027111-2016-00899
• Device Sequence Number: 439474
• Product Code: GCJ
• UDI-Device Identifier: 00607915125066
• UDI-Public: (01)00607915125066(17)190414(30)01(10)1268783
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 02/23/2017

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: 04/14/2019
• Device Model Number: CTB71
• Device Catalogue Number: 101415501
• Device Lot Number: 1268783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1