MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G-3350, 33MM INSERT S/F 15/BX; DXC

Model Number	11
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Event description: (on (b)(6) 2017: during procedure) a medical staff attached the insert to a clamp.Then the medical staff found that the insert white rubber separated from the plastic base.Another insert was used for the procedure and the procedure was completed with no problem.This event didn't affect the patient.Type of intervention: na.Patient status: "no health damage was reported for the patient.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Upon visual inspection engineering confirmed that the pad had partially separated from the insert base.It is likely that the pad had separated from the insert base due to insufficient adhesive applied to the insert base during the during the bonding process.- 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-3350, 33MM INSERT S/F 15/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6474312
• Report Number: 2027111-2017-01641
• Device Sequence Number: 18923497
• Product Code: DXC
• UDI-Device Identifier: 00607915111243
• UDI-Public: (01)00607915111243(17)200406(30)01(10)1244585
• Combination Product (Y/N): N
• PMA/510(K) Number: 11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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: Other
• Device Expiration Date: 04/06/2020
• Device Model Number: 11
• Device Catalogue Number: 11
• Device Lot Number: 1244585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1