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

Model Number	B8634
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.There is no report of serious injury or death associated with this event.
Event or Problem Description
Laser left kidney stone."plastic covering came off during operation".Additional information received on 26th august 2016.No, the wire did not come in contact with a sharp object, it was just passed through the ureteroscope.No picture available.Small plastic fragment was removed from patient and inserted in packaging with guide wire and given back to office.
Additional Manufacturer Narrative
Update - distributor to report source.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed the complainant's experience that the tubing had separated from the wire.The root cause of the tubing separation 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, to ensure the performance and safety of its products.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: B8634, UROWIRE, SIX PACK
• Common Device Name: KNY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5978871
• Report Number: 2027111-2016-00649
• Device Sequence Number: 94491
• Product Code: KNY
• UDI-Device Identifier: 00607915113858
• UDI-Public: (01)00607915113858(17)180908(30)01(10)1254760
• 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): 02/10/2017

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: 09/08/2018
• Device Model Number: B8634
• Device Catalogue Number: 100996701
• Device Lot Number: 1254760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2016
• Supplement Report FDA Received Date: 02/10/2017
• Patient Sequence Number: 1