MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX; GCJ

Model Number	CTR71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy event description: the event date is unknown.This is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation.Cannula fractured: report from the sales rep: at the end of the surgery, when the customer removed the event trocar from patient, the cannula was found to be fractured at the middle point.The fractured cannula fell off inside the abdominal cavity, but it was immediately retrieved and no patient harm was reported.Initial investigation report: the event unit was returned to us and visually inspected.The cannula was fractured.The shapes of the damaged parts are similar to each other.The cannula tip was damaged.The unit will be returned for further evaluation.(b)(4).Additional information was received via email from distributor on 25sep2018: the port was not used with a robot.The method of insertion was the hasson technique without a robot.Patient status: no patient injury.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: the event date is unknown.This is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation.Cannula fractured report from the sales rep at the end of the surgery, when the customer removed the event trocar from patient, the cannula was found to be fractured at the middle point.The fractured cannula fell off inside the abdominal cavity, but it was immediately retrieved and no patient harm was reported.Initial investigation report the event unit was returned to us and visually inspected.The cannula was fractured(pic.1).The shapes of the damaged parts are similar to each other(pic.2).The cannula tip was damaged(pic.3).The unit will be returned for further evaluation.Admin# (b)(4).Additional information was received via email from distributor on 25sep2018: the port was not used with a robot.The method of insertion was the hasson technique without a robot.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant's experience of a fractured cannula.The cannula tip was also damaged.Based on the condition of the returned unit and the description of the event, it is likely that the cannula fracture was caused by uneven wall thickness of the cannula.The damaged cannula tip was likely caused by a combination of force exerted on the tip by an instrument and exposure to a lipid saturated environment for a long duration of time.The uneven wall thickness and exposure to a lipid saturated environment could cause the cannula to be more susceptible to damage.The probability and criticality of harm resulting from this failure mode has been evaluated and were 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 process, applied medical has implemented process enhancements intended to further minimize the potential for this type of cannula fractures to occur.

• Brand Name: CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7940546
• Report Number: 2027111-2018-00375
• Device Sequence Number: 857207
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)200705(30)01(10)1300422
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: Health Professional
• Device Model Number: CTR71
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1