MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES B1005, ACUCISE ENDOPYELOTOMY SYSTEM; EYB, DXT, KOG, EZB, KNY

Model Number	B1005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This model has multiple product codes: eyb, dxt, kog, ezb, kny.This model has multiple 510(k) codes: k921838, k880987, k920030, k944135, k980987.The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Cysto rpg ureteroscopy and possible endopyelotomy - the balloon burst during surgery.It was not known how many times and how long the cutting wire was activated.The coordinator noted the product was related to a bk024 acucise pack.Type of intervention: opened a 2nd kit.Patient status: no patient injury reported.
Additional Manufacturer Narrative
The event unit was returned for evaluation.Engineering was able to confirm the complainant's experience of a ruptured balloon.There was damage observed on the coating on the cutting wire, which was charred.It is likely that the balloon ruptured due to high thermal activity of the cutting wire.The instructions for use (ifu) states, "generator setting should be at 75 watts, pure cut mode.Never use a coagulation setting.The power setting must never exceed 100 watts.And.Do not exceed 5 seconds continuous cutting time.Tissue charring, balloon rupture, and/or wire breakage can occur if 5 seconds is exceeded." 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: B1005, ACUCISE ENDOPYELOTOMY SYSTEM
• Common Device Name: EYB, DXT, KOG, EZB, KNY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6499095
• Report Number: 2027111-2017-01718
• Device Sequence Number: 1082689
• Product Code: EYB
• UDI-Device Identifier: 00607915111663
• UDI-Public: (01)00607915111663(17)180415(30)01(10)1269001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K921838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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: 04/15/2018
• Device Model Number: B1005
• Device Catalogue Number: 100540501
• Device Lot Number: 1269001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1