MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES B8634, UROWIRE, SIX PACK; EZB, KNY

Model Number	B8634
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2016
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 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
"wire stripped while threading through scope." additional information received by email on october 12, 2016.The part that stripped was the end of the wire that entered the scope first.The wire got stuck and once removed the surgeon indicated that the wire had stripped.This was during the start of the procedure where the surgeon feed the wire through the scope into the ureter.No part of the item was left inside the patient.No sharp instruments were used.We opened another wire for the surgeon to use.Patient status: "patient is fine".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed the complainant's experience that the wire had been stripped.The root cause of the stripped wire could not be determined.The tubing that had separated from the wire appeared to have been shaved or cut by a sharp instrument or surface.It is possible that when the unit was removed from the scope, it made contact with the edge of the scope, which caused the tubing to separate from the wire.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: B8634, UROWIRE, SIX PACK
• Common Device Name: EZB, KNY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6088140
• Report Number: 2027111-2016-00747
• Device Sequence Number: 1626275
• Product Code: EZB
• UDI-Device Identifier: 00607915113858
• UDI-Public: (01)00607915113858(17)180518(30)01(10)1247229
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K944135
• 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): 02/09/2017

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: 05/18/2018
• Device Model Number: B8634
• Device Catalogue Number: 100996701
• Device Lot Number: 1247229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 02/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1