MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-17 for SEAL BIOPSY VALVE SBC-365 2095-02 manufactured by Boston Scientific Corporation.
[145421449]
Date of event: the reported event date is (b)(6) 2019. However, the exact date of the event is unknown. The provided event date was chosen as a best estimate based on the event date reported. Lot #, expiration date, manufacture date: the complainant was unable to provide the lot number; therefore, the expiration and device manufacture dates are unknown. (b)(4). The device has not been received for analysis. Upon receipt and 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
[145421450]
It was reported to boston scientific corporation that a seal biopsy valve was used during a gastroscopy procedure during (b)(6) 2019. According to the complainant, while taking a biopsy in the stomach, a tiny blue particle was noticed on the set of biopsy forceps that were being used. The forceps were removed from the patient, and the particle was then removed from the forceps and set aside. During another pass, a second blue particle was noticed in the patient's stomach. The second blue particle was retrieved. It was presumed that it came from the biopsy cap, as it was the only blue artificial item in the path of the biopsy forceps. It is unknown how the procedure was completed. There was no serious injury nor adverse patient effects reported as a result of this event. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available; a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02549 |
| MDR Report Key | 8621343 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-05-17 |
| 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 | SUZHOU JINSHENG PLASTIC CO LTD |
| Manufacturer Street | NO 68 XINMEN RD XINJIA INDUSTRIAL ESTATE |
| Manufacturer City | WUZHONG DISTRICT |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEAL BIOPSY VALVE |
| Generic Name | BIOPSY VALVE |
| Product Code | OCX |
| Date Received | 2019-05-17 |
| Model Number | SBC-365 |
| Catalog Number | 2095-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2019-05-17 |