MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A0G11, STLTH FIBRA INSERT SZ 1 F/F 10/BX; DXC

Model Number	A0G11
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2016
Type of Reportable Event	Malfunction
Additional 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.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
"unknown- it was during preparation prior to clinical use." "event description: (on (b)(6) 2016) during preparation prior to clinical use;  a nurse tried to attach the insert to a clamp, however; the insert was broken unfortunately. the broken sample lot# is 1250513 or 1253684.Because a few packages from lot#1250513 and lot#1235684 had been opened at the same time for the preparation, it is difficult to identify which was the complaint lot#. no health damage has been reported with the patient.Please investigate the possible root cause.Comments from cosmotec： one (1) piece of insert was returned from the customer.We confirmed the device and found that the insert plastic part is broken.The sample will be returned to applied medical.Please investigate the possible root cause." type of intervention: "unknown." patient status: "no health damage has been reported with the patient.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering confirmed that one of the tabs located on the proximal end of the insert was 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 tabs and make it unable to remain attached to the clamp.The instructions for use (ifu) states, "to place an insert, slide the tip of the clamp into the closed end of the insert.Press the insert onto the clamp by applying pressure at the tip and sliding the thumb across the insert towards the proximal end." 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: A0G11, STLTH FIBRA INSERT SZ 1 F/F 10/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5837191
• Report Number: 2027111-2016-00550
• Device Sequence Number: 18981954
• Product Code: DXC
• UDI-Device Identifier: 00607915114794
• UDI-Public: (01)00607915114794(17)200708(30)01(10)1250513
• Combination Product (Y/N): N
• PMA/510(K) Number: K950492
• 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: 07/08/2020
• Device Model Number: A0G11
• Device Catalogue Number: 100736601
• Device Lot Number: 1250513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2016
• Supplement Report FDA Received Date: 05/11/2017
• Patient Sequence Number: 1