MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-17 for B1005, ACUCISE ENDOPYELOTOMY SYSTEM 100540501 manufactured by Applied Medical Resources.
[73259208]
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.
Patient Sequence No: 1, Text Type: N, H10
[73259209]
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.
Patient Sequence No: 1, Text Type: D, B5
[76684055]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2017-01718 |
| MDR Report Key | 6499095 |
| Date Received | 2017-04-17 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-03-17 |
| Date Mfgr Received | 2017-03-17 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2017-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497133904 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B1005, ACUCISE ENDOPYELOTOMY SYSTEM |
| Generic Name | EYB, DXT, KOG, EZB, KNY |
| Product Code | EYB |
| Date Received | 2017-04-17 |
| Returned To Mfg | 2017-03-15 |
| Model Number | B1005 |
| Catalog Number | 100540501 |
| Lot Number | 1269001 |
| Device Expiration Date | 2018-04-15 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-17 |