MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G-6155, 61MM INSERT F/F 15/BX; DXC

Model Number G-6155

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: "unknown" incident description: a medical staff tried to attach the insert to a clamp.Then the medical staff found that the part of fibra was peeled off from the rubber base.Another insert was used for the procedure and the procedure was completed with no problem.It didn't affect the patient." type of intervention: "another insert was used for the procedure and the procedure was completed with no problem." patient status: "it didn't affect the patient.".

Manufacturer Narrative

Investigation summary: the event unit was returned to applied medical for evaluation.Upon visual inspection engineering confirmed that the fibra layer had partially separated from the insert pad.Based on the condition of the returned unit, the exact root cause of the event could not be determined.The probability and criticality of harm resulting from this failure mode 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.

• Brand Name: G-6155, 61MM INSERT F/F 15/BX
• Type of Device: DXC
• 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: 7068013
• MDR Text Key: 93816983
• Report Number: 2027111-2017-02134
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607915111274
• UDI-Public: (01)00607915111274(17)201121(30)01(10)1260098
• Combination Product (y/n): N
• PMA/PMN Number: K883790
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/21/2020
• Device Model Number: G-6155
• Device Catalogue Number: 100063301
• Device Lot Number: 1260098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1