MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-29 for STONEBREAKER PNEUMATIC LITHOTRIPTER SBL-KIT1 manufactured by Cook Inc.
[112836498]
Common name: ffk lithotriptor, electro-hydraulic, product code: ffk. Pma/510k #: k062475 (b)(4). Sterilization date: (b)(6) 2009. Device is in transit to the manufacturer as it pertains to removal (b)(4) not related to this failure mode. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[112836499]
It was reported during a percutaneous nephrolithotomy (pcnl) procedure after the ureteral catheterization when the patient should have been turned to prone position the nurse put the cartridge in the stonebreaker pneumatic lithotripter and found the cartridge was leaking next to the incising needle. They attempted to tighten the cartridge and tried a new cartridge, but couldn't get the device to work. The device was reported to not have had contact with the patient. The procedure was cancelled. Procedure has been postponed until (b)(6). It was reported that the patient had 3 extracorporeal shock wave lithotripsy (eswl) procedures in the past. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01834 |
| MDR Report Key | 7651960 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-29 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-06-08 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2018-06-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONEBREAKER PNEUMATIC LITHOTRIPTER |
| Product Code | FFK |
| Date Received | 2018-06-29 |
| Returned To Mfg | 2018-07-23 |
| Catalog Number | SBL-KIT1 |
| Lot Number | 0900573 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-29 |