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 2019-03-20 for SEAL BIOPSY VALVE SBC-501-100 2235-01 manufactured by Boston Scientific Corporation.
[139343524]
The complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown. 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
[139343525]
It was reported to boston scientific corporation that a seal biopsy valve was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the biopsy valve popped off the scope and discharge came out of the scope. Another seal biopsy valve was used to complete the case. There was no serious injury nor adverse patient effects reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01274 |
| MDR Report Key | 8437030 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-03-20 |
| 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 | NOLATO CONTOUR INC |
| Manufacturer Street | 660 VANDEBERG STREET , |
| Manufacturer City | BALDWIN WI 54002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEAL BIOPSY VALVE |
| Generic Name | SEAL BIOPSY VALVE |
| Product Code | OCX |
| Date Received | 2019-03-20 |
| Model Number | SBC-501-100 |
| Catalog Number | 2235-01 |
| 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 | 2019-03-20 |