MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-06-12 for 3.8 MM X 403 MM ULTRASOUND PROBE M0068407170 840-717 manufactured by Boston Scientific - Spencer.
[5943261]
It was reported to boston scientific corporation that an ultrasound probe was used during a percutaneous nephrolithotomy procedure on (b)(6) 2015. According to the complainant, during the procedure, the probe broke at the bottom third of the device and fell inside the patient. Grasping forceps were used to successfully retrieve the broken probe fragment and no pieces of the device were left inside the patient. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event and the patient? S condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[13365158]
Reported event of? Probe broke.? Although the suspect device has been received, the evaluation has not been completed. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[24683947]
A visual examination confirmed that the returned device was broken at approximately 5. 2 cm from the hub. The working length of the device was not bent and did not present any noticeable surface scratching. A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution. A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label. Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined; therefore, the root cause classification is undeterminable.
Patient Sequence No: 1, Text Type: N, H10
[24684008]
It was reported to boston scientific corporation that an ultrasound probe was used during a percutaneous nephrolithotomy procedure on (b)(6) 2015. According to the complainant, during the procedure, the probe broke at the bottom third of the device and fell inside the patient. Grasping forceps were used to successfully retrieve the broken probe fragment and no pieces of the device were left inside the patient. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2015-01672 |
| MDR Report Key | 4840296 |
| Report Source | 05,07 |
| Date Received | 2015-06-12 |
| Date of Report | 2015-05-20 |
| Date of Event | 2015-05-20 |
| Date Mfgr Received | 2015-07-10 |
| Device Manufacturer Date | 2014-10-10 |
| Date Added to Maude | 2015-06-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.8 MM X 403 MM ULTRASOUND PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2015-06-12 |
| Returned To Mfg | 2015-05-29 |
| Model Number | M0068407170 |
| Catalog Number | 840-717 |
| Lot Number | 17352158 |
| Device Expiration Date | 2017-10-08 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-12 |