MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-04 for PKG., BARREL BUR, 12 FLUTE F - SERIES - 4.0MM 0375941012 manufactured by Stryker Endoscopy-san Jose.
[182024963]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[182024964]
It was reported that the device broke and potentially remains in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2020-00117 |
| MDR Report Key | 9787452 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-03-04 |
| 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 | MR. ANDREA ZENERE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PKG., BARREL BUR, 12 FLUTE F - SERIES - 4.0MM |
| Generic Name | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL |
| Product Code | GFA |
| Date Received | 2020-03-04 |
| Catalog Number | 0375941012 |
| Lot Number | 19226CE2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-04 |