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

Model Number CTB12

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2016

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 additional information received, it is likely that the reported event was caused by a malfunction of the switch component.However, in the absence of the event unit, it is difficult to determine the exact root cause of the event.The probability and criticality 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 based on the description of the event during initial intake of the complaint, the event was not reportable as it was unlikely to cause or contribute to death or serious injury.After additional information was received, the event is now reportable.This report represents the combined initial and final.

Event Description

Procedure performed: laparoscopy event description: the trocar spike of 5 mm, defect = impossible to trigger the issue of the knife, the cursor does not hold.Clinical consequences: entry into force.Original: la pique du trocard de 5 mm, défaut = impossible d'enclencher l'issue du couteau, le curseur ne tient pas.Conséquences cliniques : entrée en force.Additional information received via email from sales representative on 15aug2017: additional questions were asked to the or-team, but it's a very old case and nobody seems to be able to answer the questions.Additional information received via email from sales representative on 21aug2017: blade forcefully exposed during the force introduction of the trocar because the cursor did not remain engaged.No piece fall into the patient.The non-conformance was identified at the beginning of the procedure.Risk taking since there is no safety of retraction of the blade type of intervention: unknown.Patient status: unknown.

• Brand Name: CTB12, 5X100 KII SH BLD ZTHR DP 10/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: 6877798
• MDR Text Key: 86792156
• Report Number: 2027111-2017-02003
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123529
• UDI-Public: (01)00607915123529(17)190713(30)01(10)1273892
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2019
• Device Model Number: CTB12
• Device Catalogue Number: 101413701
• Device Lot Number: 1273892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1