MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; GCJ

Model Number C0R50

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.Based on the description of the event, it is likely that the reported event occurred when the shield, an internal plastic component of the seal, was unseated from the seal.It is likely that the shield was unseated during removal of the scope, which then made it difficult to insert the scope.The probability and critically of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.This report represents the combined initial and final.

Event Description

Procedure performed: prostatectomy.Event description: during prostatectomy robot, impossible to put the optic in the trocar open after having cleaned it.Difficult to prevent this risk without using the trocar.Additional information received from the sales rep via email on 7 sep 2017 at 6:23 pm the device is not available for evaluation, the hospital has discarded the unit.The prostatectomy under laparo robot assisted was carried out by dr [name] , urologist at the clinic (b)(6).During the operation, the optics was removed from the open trocar, reference c0r50 in order to be cleaned, but when it was necessary to put it back in this trocar, it was impossible.Another trocar c0r50 has been installed.The optic was not able to pass through the seal.Type of intervention: change the trocar.Patient status: no impact on the patient health.

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 6914376
• MDR Text Key: 89775147
• Report Number: 2027111-2017-02016
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)200327(30)01(10)1292480
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1292480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1