MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G-4550, 45MM INSERT S/F 15/BX; DXC

Model Number 13

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.

Event Description

Event description: (on (b)(6) 2017: during a preparation), a medical staff tried to attach the insert g4550 to a clamp, however; it did not fit.Another package of insert was opened but the medical staff confirmed deformation at the button.Thus the medical staff canceled to use the second one.This event didn't affect the patient.Additional information received via email from distributor april 5, 2017 - the defects for the g-4550 were noticed before the procedure.Procedure performed: unknown.Type of intervention: na.Patient status: no health damage was reported for the patient.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering determined that the male attachment features (buttons) of the insert were damaged, which would affect the unit's ability to attach to the clamp.It is likely that the root cause of the event was improper technique during installation of the insert, as this can cause damage to the attachment features of the insert and make it unable to remain attached to the clamp.The instructions for use (ifu) states, "to place inserts, open the clamp to spread both clamp jaws.Place the button located on the proximal end of the insert into the mounting hole.Snap the other button into the clamp by pressing forward and down on the insert with firm hand pressure.Do not press down directly on this button."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.

• Brand Name: G-4550, 45MM INSERT S/F 15/BX
• Type of Device: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497133904
• MDR Report Key: 6513684
• MDR Text Key: 73516904
• Report Number: 2027111-2017-01729
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607915111380
• UDI-Public: (01)00607915111380(17)180204(30)01(10)1188662
• Combination Product (y/n): N
• PMA/PMN Number: 13
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/04/2018
• Device Model Number: 13
• Device Catalogue Number: 13
• Device Lot Number: 1188662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1