MAUDE Adverse Event Report: AMR INSERT; DXC

Model Number	G8655
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided 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
Procedure performed: unknown, it was during device use check before starting an operation.During device use check before starting an operation: a nurse tried to attach the insert to a clamp made by applied medical.Unfortunately the insert.Was not attached to and fell off from the clamp.Another pack of insert from the same lot was opened.However, the second pair of insert was not attached to and fell off again.Another pack of insert from the same lot was opened for the third try.The third pair of insert was successfully attached and used for the operation.There was no impact to the operation.No health damage has been reported with the patient.Please investigate the possible root cause.Comments from cosmotec: "two (2) units of insert were returned from the customer.We confirmed the devices and found that some of the attachment buttons were shaved.The samples will be returned to applied medical.Please investigate the possible root cause." additional info received: june 15, 2016.What clamp was being used with these inserts? -the customer used a clamp made by applied medical with the complaint inserts.Patient status: "no health damage has been reported with the patient.".
Additional Manufacturer Narrative
Investigation summary: the event device was returned for evaluation.Upon visual inspection, it was confirmed that the insert had been damaged.The most likely root cause is improper technique when the user attached the inserts to the surgical clamp.The instructions for use (ifu) provide the following directions: "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." although the exact root cause of the complainant's experience could not be confirmed, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: INSERT
• Common Device Name: DXC
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5749465
• Report Number: 2027111-2016-00482
• Device Sequence Number: 10918080
• Product Code: DXC
• UDI-Device Identifier: 00607915111298
• UDI-Public: (01)00607915111298(17)200425(30)01(10)1245351
• Combination Product (Y/N): N
• PMA/510(K) Number: K883790
• 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): 12/16/2016

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: 04/25/2020
• Device Model Number: G8655
• Device Catalogue Number: 100063501
• Device Lot Number: 1245351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2016
• Supplement Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1