MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-04 for ULTRASOUND PROBE 69210 manufactured by Boston Scientific Corporation.
[129333791]
Date of event: date of event was approximated to? (b)(6) 2018,? As no exact event date was reported. User facility reference number: (b)(4). (b)(4). Captures the reportable event of probe broke. Visual examination of the returned ultrasound probe revealed that it was broken about 10cm from the head. Therefore, a review and analysis of all available information indicated that the root cause is adverse event related to procedure. A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on event.
Patient Sequence No: 1, Text Type: N, H10
[129333792]
It was reported to boston scientific corporation on (b)(6) 2018 that a lithoclast 3. 8mm x 403mm ultrasound disposable probe was used in a procedure performed on (b)(6)2018. According to the complainant, during the procedure, the ultrasound probe got busted. Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event. Should additional relevant details become available, a supplemental report will be submitted. Note: this event has been deemed an mdr-reportable event based on investigation results, which revealed that the ultrasound probe was broken and because of the ambiguity of where the fragments detached. Please refer to block h10 for full investigation details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61642 |
| MDR Report Key | 8130471 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-04 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-11-21 |
| Device Manufacturer Date | 2018-06-12 |
| Date Added to Maude | 2018-12-04 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | ELECTRO MEDICAL SYSTEMS SA |
| Manufacturer Street | CH. DE LA VUARPILLI CH-1260, |
| Manufacturer City | NYON, SZ 1260 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 1260 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASOUND PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2018-12-04 |
| Returned To Mfg | 2018-08-15 |
| Model Number | 69210 |
| Catalog Number | 69210 |
| Lot Number | 0022240371 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-04 |