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 2018-12-21 for EMS SWISS LITHOCLAST LITHOTRIPTER manufactured by Boston Scientific Corporation.
[131129349]
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported. The complainant was unable to provide the suspect device upn and lot number. Therefore, the lot expiration and device manufacture dates are unknown. (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
[131129350]
It was reported to boston scientific corporation on (b)(6) 2018 that a lithoclast disposable probe was used during a ureteroscopy for bladder augmentation procedure performed on an unknown date. According to the complainant, during the procedure, a combination of ultrasound and pneumatic setup was used and the probe overheated. The penis of the patient burned while advancing the probe into the urethra. The burn was treated with silvadene cream. The patient was fine and there was no serious injury to patient as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-62146 |
| MDR Report Key | 8188858 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2018-12-21 |
| 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 | 2018-12-21 |
| 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 | 2018-12-21 |