MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for SEAL? SBC-365 manufactured by Endochoice, Inc..
[141479622]
When taking a biopsy of the stomach a tiny blue particle was noticed on the biopsy forceps. Forceps were immediately removed and particle placed on 4x4 for staff to obtain a picture. On another pass another particle was noticed in the patient's stomach. It was presumed that it came from the biopsy cap as it was the only blue artificial item in the path the biopsy forceps took. The device was saved and will be returned for failure analysis. The additional blue particle was retrieved and no harm came to the patient. Microscope images were obtained from the biopsy cap and are attached to this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8499638 |
| MDR Report Key | 8499638 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-02-05 |
| Report Date | 2019-02-25 |
| Date Reported to FDA | 2019-02-25 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEAL? |
| Generic Name | ENDOSCOPIC IRRIGATION/SUCTION SYSTEM |
| Product Code | OCX |
| Date Received | 2019-04-10 |
| Model Number | SBC-365 |
| Lot Number | 170425 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ENDOCHOICE, INC. |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Brand Name | SEAL? |
| Generic Name | ENDOSCOPIC IRRIGATION/SUCTION SYSTEM |
| Product Code | OCX |
| Date Received | 2019-04-10 |
| Model Number | SBC-365 |
| Lot Number | 170425 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOCHOICE, INC. |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |