MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-08-15 for LMA STONEBREAKER PNEUMATIC LITHOTRIPTER SBL-KIT1 manufactured by Cook Inc.
[117141853]
Additional information: common device name/procode: ffk. (b)(4). This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[117141854]
It was reported that the stonebreaker pneumatic lithotripter had a leak in the cartridge due to a faulty joint, requiring the physician to use open surgery to complete the procedure. The complaint device did not make patient contact, and there were no further injuries aside from the additional procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02521 |
| MDR Report Key | 7784549 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-15 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-08-15 |
| 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 Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| 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 | LMA STONEBREAKER PNEUMATIC LITHOTRIPTER |
| Product Code | FFK |
| Date Received | 2018-08-15 |
| Returned To Mfg | 2015-09-29 |
| Catalog Number | SBL-KIT1 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2018-08-15 |