MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for PROXIMATE PRW35 manufactured by Ethicon Endo-surgery, Llc.
[185056566]
Operating room staff reported that a stapler was not working during a procedure. A new stapler was opened and used without issue. The procedure was completed as planned with no harm to the patient, and the stapler will be returned to the manufacturer by or material's management staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882561 |
| MDR Report Key | 9882561 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-23 |
| Report Date | 2020-02-14 |
| Date Reported to FDA | 2020-02-14 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| 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 | 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 | PROXIMATE |
| Generic Name | STAPLE, REMOVABLE (SKIN) |
| Product Code | GDT |
| Date Received | 2020-03-26 |
| Model Number | PRW35 |
| Catalog Number | PRW35 |
| Lot Number | T40Z7W |
| Device Availability | * |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Address | 475 CALLE C GUAYNABO PR 00969 US 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |