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 2018-09-27 for EMS SWISS LITHOCLAST LITHOTRIPTER UNK-M-69210 69210 manufactured by Boston Scientific Corporation.
[121852656]
The complainant was unable to provide the device lot number. Therefore, the manufacture and expiration dates are unknown. It was reported that the device was not used past its expiry date. (b)(4). The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[121852657]
It was reported to boston scientific corporation on august 29, 2018 that a swiss lithoclast ultrasonic probe was used during procedure performed on (b)(6) 2018. According to the complainant, during the procedure, the ultrasound probe broke off inside the patient and the broken pieces were retrieved with a grasper. Reportedly, the probe has been re-processed three times prior to the procedure. This probe can be re-processed up to five times. The procedure was completed with another lithoclast ultrasonic probe. There were no serious injury/adverse effect to patient as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-60527 |
| MDR Report Key | 7913806 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-09-27 |
| 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 | 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 | EMS SWISS LITHOCLAST LITHOTRIPTER |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2018-09-27 |
| Model Number | UNK-M-69210 |
| Catalog Number | 69210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2018-09-27 |