MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for LF4318 manufactured by Stryker Sustainability Solutions, Inc..
[118254460]
The automatic component of the staple device broke off with first use. The broken item obtained and removed from field. The broken item taped to device and new device obtained. No harm to patient. Surgery continued without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7816914 |
| MDR Report Key | 7816914 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-07-29 |
| Report Date | 2018-08-20 |
| Date Reported to FDA | 2018-08-20 |
| Date Reported to Mfgr | 2018-08-27 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Generic Name | ELECTROSURGICAL, CUTTING, COAGULATION, REPROCESSED |
| Product Code | NUJ |
| Date Received | 2018-08-27 |
| Model Number | LF4318 |
| Catalog Number | LF4318 |
| Lot Number | 6895711 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| Manufacturer Address | 1810 W. DRAKE DR. TEMPE AZ 85283 US 85283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-27 |